Phase I study of LY573636-sodium, an acylsulfonamide anti-cancer compound with a novel mechanism of action, administered as 24-hour continuous infusion in patients with advanced solid tumors

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2542-2542 ◽  
Author(s):  
C. A. Slapak ◽  
P. M. LoRusso ◽  
D. Mendelson ◽  
A. K. Sykes ◽  
D. P. De Alwis ◽  
...  
Keyword(s):  
Phase I ◽  
Mechanism Of Action ◽  
Half Life ◽  
Phase I Study ◽  
Uterine Cancer ◽  
Phase 1 ◽  
Maximum Tolerated Dose ◽  
Flat Dose ◽  
Anti Cancer ◽  
Dosing Strategy

2542 Background: LY573636 -sodium (hereafter referred to as LY573636 ) is a novel anti-cancer compound that induces apoptosis by a mitochondrial-mediated mechanism. Methods: A phase I study was conducted to determine the maximum tolerated dose and pharmacokinetic (PK) profile of LY573636 administered as a 24-hour continuous intravenous (IV) infusion every 28 days. Results: 26 patients (pts) were enrolled on study, 12 males and 14 females, with a median age of 57 (range: 41–74). LY573636 was dose-escalated using a flat dosing-based schema. No dose limiting toxicity (DLT) was observed until the 2,000 mg cohort, when 1 pt developed CTCAE grade 3 hyperbilirubinemia. PK analysis revealed that LY573636 had a low total plasma clearance (CL = 0.02L/hr) and a terminal elimination half-life of approximately 340 hours due to high-albumin binding (∼99%). One additional pt in the 2,000 mg flat dose cohort developed grade 4 thrombocytopenia in cycle 2, possibly due to the accumulation of albumin-bound drug. Based on these PK and clinical data, the dosing strategy was revised to a flat loading/maintenance dose regimen of 2,500 mg/1,750 mg every 28 days by 24-hour continuous IV infusion. Thirteen pts were treated at this dose level, with 1 pt experiencing a DLT of grade 4 leukopenia. Overall, 8/26 pts had stable disease (SD) after 2 or more cycles, with 2 pts still on study. Five pts received ≥ 4 cycles (SD ≥ 4 mos), including heavily pre-treated pts with ovarian cancer, soft tissue sarcoma, and uterine cancer. Conclusions: LY573636 is a novel anti-cancer compound with a unique mechanism of action. The most common DLT was BM suppression. Because of the long half-life of LY573636 , and the encouraging findings of a separate IV bolus phase 1 study, an IV bolus-based regimen will be taken forward into phase 2 study. No significant financial relationships to disclose.

Phase I study of LY573636-sodium, an acylsulfonamide anti-cancer compound with a novel mechanism of action, administered as 2-hour IV infusion in patients with advanced solid tumors

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2515-2515 ◽  
Author(s):  
R. L. Ilaria ◽  
G. R. Simon ◽  
M. Sovak ◽  
M. K. Burton ◽  
A. L. Cleverly ◽  
...  
Keyword(s):  
Phase I ◽  
Mechanism Of Action ◽  
Phase I Study ◽  
Maximum Tolerated Dose ◽  
Dose Finding ◽  
Lean Body Weight ◽  
Flat Dose ◽  
Elimination Half ◽  
Anti Cancer ◽  
Grade 3

2515 Background: LY573636 -sodium (hereafter referred to as LY573636 ) is a novel anti-cancer compound that induces apoptosis by a mitochondrial-mediated mechanism. Methods: A phase I study was conducted to determine the maximum tolerated dose (MTD) and pharmacokinetic (PK) profile of LY573636 administered as an intravenous infusion over 2 hours every 21 days. Results: 53 patients (pts) were enrolled on study, 16 males, 37 females, with a median age of 58 (range: 18–83). LY573636 was dose-escalated using a flat dosing paradigm in the first 34 patients (range 100 mg to 2400 mg). PK analysis of this cohort revealed that LY573636 had a low total plasma clearance (CL = 0.02L/hr) and terminal elimination half-life of approximately 340 hours due to high-albumin binding (∼99%). The dose limiting toxicity (DLT) for the flat dose escalation was bone marrow (BM) suppression, which included CTC (ver2) grade 3/4 thrombocytopenia/neutropenia. In some patients, significant BM suppression occurred in cycle 2 and later, attributed to the accumulation of albumin-bound drug with repeated flat dosing. Based on these findings, the dose-finding strategy was modified to an idealized dosing paradigm which calculated LY573636 doses based on pt lean body weight, and used a loading/maintenance dose regimen to achieve a specific Cmax target value. All 3 pts in the first 400 μg/mL Cmax cohort completed at least 2 cycles and no DLTs were reported. Of the 16 pts enrolled to the 420 μg/mL targeted dose group: 1 pt reported a DLT, a transient grade 3 elevation of ALT/AST which did not recur in subsequent cycles; 8/16 pts received 4 or more cycles prior to disease progression and 2 remain on treatment. Overall, 23/53 pts had stable disease (SD) after 2 or more cycles. Seven pts received >8 cycles (SD > 6 mos), including heavily pre-treated pts with ovarian cancer, non-small cell lung cancer, soft tissue sarcoma, and thymoma. Conclusions: LY573636 is a novel anti-cancer compound with a unique mechanism of action. The most common DLT was BM suppression. The individualized, target Cmax dose of 420 μg/mL has been taken forward into phase II clinical trials. No significant financial relationships to disclose.

scholarly journals Phase I study protocol: NKTR-255 as monotherapy or combined with daratumumab or rituximab in hematologic malignancies

2021 ◽  
Author(s):  
Nina Shah ◽  
Miguel-Angel Perales ◽  
Cameron J Turtle ◽  
Mitchell S Cairo ◽  
Andrew J Cowan ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Study ◽  
Hematologic Malignancies ◽  
Maximum Tolerated Dose ◽  
Multiple Cancer ◽  
Cancer Models ◽  
Anti Cancer ◽  
Recommended Phase Ii Dose ◽  
And Function ◽  
Anti Tumor Activity

NKTR-255 is an investigational polyethylene glycol-modified recombinant human IL-15 (rhIL-15) receptor agonist, designed to improve the immunotherapeutic and anti-cancer benefit observed with rhIL-15 while circumventing the toxicities associated with this therapy. In preclinical studies, NKTR-255 has demonstrated enhanced proliferation and function of CD8+ T cells and natural killer cells, as well as enhanced anti-tumor activity and survival both as monotherapy and in combination with monoclonal antibodies in multiple cancer models. Here, we describe the rationale and design of the first-in-human Phase I, dose-escalation and dose-expansion study of NKTR-255 alone and in combination with daratumumab or rituximab in adults with relapsed/refractory multiple myeloma or non-Hodgkin's lymphoma that will determine the maximum tolerated dose and recommended Phase II dose for NKTR-255.

Phase I Study of Elotuzumab (HuLuc63) in Phase I Study of Elotuzumab (HuLuc63) in Relapsed/Refractory Multiple Myeloma

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2773-2773 ◽  
Author(s):  
Jeffrey A. Zonder ◽  
Seema Singhal ◽  
William Bensinger ◽  
Ann Mohrbacher ◽  
Mohamad A. Hussein ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Phase I ◽  
Stable Disease ◽  
Half Life ◽  
Phase I Study ◽  
Maximum Tolerated Dose ◽  
Primary Objective ◽  
Surface Glycoprotein ◽  
Cell Surface Glycoprotein ◽  
Higher Doses

Abstract Elotuzumab is a humanized monoclonal antibody directed against CS1, a cell surface glycoprotein, which is highly and uniformly expressed in multiple myeloma. Elotuzumab has demonstrated significant anti-tumor activity in pre-clinical mouse models of multiple myeloma (MM). The primary objective of this Phase I study is to evaluate the maximum tolerated dose (MTD) of elotuzumab in patients with relapsed/refractory MM. The study also evaluates the overall safety, pharmacokinetics (PK), biologic activity and clinical response to elotuzumab. Elotuzumab is administered every 2 weeks × 4 doses in six escalating dose cohorts ranging from 0.5 mg/kg to 20 mg/kg. An additional 4 doses may be administered if the patient demonstrates at least stable disease during the initial 4 doses of therapy. To date, a total of 23 patients, 52% male, with a median age of 64 years and a median of seven prior treatments, have been treated in the six cohorts. In the 2.5 mg/kg cohort, one out of six patients experienced a DLT of Grade 4 increase in serum creatinine which was concomitant to an unrelated serious adverse event (SAE) of sepsis. Four additional elotuzumab-related SAEs in two patients (Grade 2 chills and fever in one subject in the 2.5 mg/kg cohort, Grade 2 chest pressure and bradycardia in another subject in the 10 mg/kg cohort, all requiring overnight hospitalization) have been observed. However, the MTD for elotuzumab has not been reached up to the 10 mg/kg dose. Several patients (10/16) experienced Grade 1 and 2 AEs occurring during or immediately after the first dose including chills, flushing, pyrexia, rigors, dyspnea and fatigue. An increase in serum levels of a number of cytokines such as interferon-gamma and TNF-alpha, and chemokines including IP10 and MCP1 was observed for all patients following the first dose of elotuzumab, peaking between 2–4h after the end of infusion and returning to near baseline levels by 24h. These infusion-related symptoms were not observed during the subsequent dosing of elotuzumab, possibly due to premedication with antihistamines and acetaminophen. Preliminary PK analysis suggests a short serum half-life of 2–4 days at low doses of elotuzumab (0.5–2.5 mg/kg), with an increase to 10–11 days at higher doses (5–10 mg/kg). Cmax levels of 53–114 mcg/mL and 291–384 mcg/mL were observed in the 5 mg/kg and 10 mg/kg cohorts, respectively. Following the completion of 4 doses of elotuzumab, 6 patients demonstrated stable disease, four of these at 5 mg/kg or higher dose levels, according to the EBMT response criteria. In summary, elotuzumab appears to have a manageable safety profile in patients with relapsed/refractory MM. MTD for elotuzumab has not been reached up to the 10 mg/kg dose. Higher doses of elotuzumab lead to a significant increase in Cmax and half-life. Evaluation of the 20 mg/kg dose cohort is ongoing.

Phase I study (A8471004) in Asian patients of PF-03446962, a fully human mab against ALK-1 receptor involved in tumor angiogenesis: Safety, pharmacokinetics (PK), and pharmacodynamics (PD).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 11031-11031
Author(s):  
Kyung-Hun Lee ◽  
Toshihiko Doi ◽  
Tae Min Kim ◽  
Atsushi Ohtsu ◽  
Tae Yong Kim ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Study ◽  
Drug Exposure ◽  
Phase 1 ◽  
Maximum Tolerated Dose ◽  
Primary Objective ◽  
Clinical Activity ◽  
Vegf Inhibitors ◽  
Study Results ◽  
Dose Levels

11031 Background: Activin receptor like kinase 1 (ALK-1) is a member of the TGF-βRI family selectively expressed in proliferating endothelial cells, and plays an important role in regulating tumor initiation and metastasis. PF-03446962 is a fully human IgG2 mAb anti ALK-1 evaluated within two phase 1 studies in Western and Asian pts. Herein we report the preliminary safety, PK and PD data of the Phase I study. Methods: Primary objective is to identify the maximum tolerated dose (MTD) in Asian cancer pts; secondary objectives include the safety profile, PK, antitumor activity, and potential PD markers in blood and tumor samples. PF-03446962 is administered IV on Day 1, 29 and then q 2 weeks. Results: Study A8471004 consists of two parts: a 3+3 dose escalation (Part 1) and a dose expansion (Part 2) at 2 dose levels. In Part 1, 16 pts have been enrolled at 3 dose levels (4 pts at 4.5 mg/kg, 3 pts at 7.0 mg/kg, and 9 pts at 10 mg/kg). No DLTs occurred in Part 1 and 10 mg/kg was confirmed as MTD in the Asian population. The observed AUC0-28day for the 4.5, 7 and 10 mg/kg doses, were 12960, 22190 and 28030 μg·h/mL and Cmax were 97.1, 131.5 and 179.8 μg/mL, respectively. Drug exposure (mean Cmax and AUC) increased in a nearly dose proportional manner in Asians. In Part 2, expansion cohorts at doses of 7.0 mg/kg (10pts) and 10.0 mg/kg (8pts) of pts previously treated with VEGF inhibitors (VEGFi) have been enrolled, and the most common drug related adverse events observed (>10%) being thrombocytopenia, pyrexia, epistaxis, and telangiectasia (an anti-ALK-1 mediated toxicity) similarly in the 2 dose levels. Telangiectasia was observed in 1 CRC and 3 HCC patients. 4 patients who progressed after VEGFi treatment (RCC, sarcoma, 2 HCC patients) presented a SD lasting for 290, 248, 247 and 208 days, respectively, suggesting the ALK-1 could serve as mechanism of escape for VEGF. Conclusions: PF-03446962 is a first in class mAb targeting ALK-1. Treatment with PF-03446962 is well tolerated in the Asian pts and preliminary observation of clinical activity supports ALK-1 as a viable target. Update of study results and potential PD effects obtained on blood and tumor samples will be presented. Clinical trial information: NCT01337050.

scholarly journals EPCT-19. A PHASE I STUDY OF RIBOCICLIB AND EVEROLIMUS FOLLOWING RADIATION THERAPY IN CHILDREN WITH NEWLY DIAGNOSED NON-BIOPSIED DIFFUSE PONTINE GLIOMAS (DIPG) AND RB+ BIOPSIED DIPG AND HIGH GRADE GLIOMAS (HGG)

2020 ◽  
Vol 22 (Supplement_3) ◽  
pp. iii307-iii307
Author(s):  
Mariko DeWire ◽  
James Leach ◽  
Christine Fuller ◽  
Peter de Blank ◽  
Trent Hummel ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Study ◽  
Single Agent ◽  
Maximum Tolerated Dose ◽  
Pharmacokinetic Studies ◽  
High Grade ◽  
Newly Diagnosed ◽  
High Grade Gliomas ◽  
Grade 3 ◽  
Expansion Cohort

Abstract Genomic aberrations in the cell cycle and mTOR pathways have been reported in diffuse pontine gliomas (DIPG) and high-grade gliomas (HGG). Dual inhibition of CDK4/6 (ribociclib) and mTOR (everolimus) has strong biologic rationale, non-overlapping single-agent toxicities, and adult clinical experience. The maximum tolerated dose (MTD) and/or recommended phase two dose (RP2D) of ribociclib and everolimus administered during maintenance therapy following radiotherapy was determined in the phase I study as a rolling 6 design. Ribociclib and everolimus were administered once daily for 21 days and 28 days, respectively starting two-four weeks post completion of radiotherapy. All HGG patients and any DIPG patient who had undergone biopsy were screened for RB protein by immunohistochemistry. Eighteen eligible patients enrolled (median age 8 years; range: 2–18). Six patients enrolled at dose levels 1,2, and 3 without dose limiting toxicities (DLT). Currently, five patients are enrolled at dose level 3 expansion cohort. The median number of cycles are 4.5 (range: 1–20+). Among the expansion cohort, one dose limiting toxicity included a grade 3 infection and one patient required a dose reduction in course 3 due to grade 3 ALT and grade 4 hypokalemia. The most common grade 3/4 adverse events included neutropenia. Preliminary pharmacokinetic studies on 12 patients suggest an impact of ribociclib on everolimus pharmacokinetics. The MTD/RP2D of ribociclib and everolimus following radiotherapy in newly diagnosed DIPG and HGG is anticipated to be 170 mg/m2/day x 21 days and 1.5 mg/ m2/day every 28 days which is equivalent to the adult RP2D.

scholarly journals Multicenter phase 1 trial of intraventricular immunochemotherapy in recurrent CNS lymphoma

Blood ◽  
2013 ◽  
Vol 121 (5) ◽  
pp. 745-751 ◽  
Author(s):  
James L. Rubenstein ◽  
Jing Li ◽  
Lingjing Chen ◽  
Ranjana Advani ◽  
Jan Drappatz ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Study ◽  
Phase 1 ◽  
Cns Lymphoma ◽  
Phase 1 Trial ◽  
Multicenter Phase ◽  
Key Points

Key Points Phase I study showed that intraventricular rituximab plus methotrexate is feasible and active in the treatment of refractory CNS lymphoma.

A phase I study of an IDO inhibitor (SHR9146) plus camrelizumab and in combination with/without apatinib in patients with advanced solid tumors: Safety and efficacy analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3101-3101
Author(s):  
Ying Cheng ◽  
Ying Liu ◽  
Jinhua Xu ◽  
Jing Zhu ◽  
Ying Wang ◽  
...  
Keyword(s):  
Partial Response ◽  
Phase I ◽  
Solid Tumors ◽  
Renal Cancer ◽  
Phase I Study ◽  
Angiogenesis Inhibitor ◽  
Maximum Tolerated Dose ◽  
Advanced Solid Tumors ◽  
Open Label ◽  
Safety And Efficacy

3101 Background: IDO is an enzyme of interest in immuno-oncology because of the immunosuppressive effects that result from its role in tryptophan catabolism. Clinical trials of IDO inhibitors with immunotherapy are under active investigation. The addition of angiogenesis inhibitor may further enhance the anti-tumor immune responses. Here we report the safety and efficacy results of SHR9146 (IDO inhibitor) plus camrelizumab (PD-1 antibody) with/without apatinib (VEGFR-2 inhibitor) in patients (pts) with advanced solid cancers who failed standard antitumor therapies. Methods: This was an open-label, phase I study. Eligible puts would receive SHR9146 (escalated dose) plus camrelizumab (200 mg IV, q2w) alone (Cohort A) or in combination with apatinib (250 mg p.o. qd) (Cohort B). Each cohort was conducted according to a 3+3 dose escalation design. The starting dose of SHR9146 was 100mg bid, followed by 200, 400, 600 mg bid. The two primary endpoints were Dose-limiting Toxicity (DLT) and Maximum Tolerated Dose (MDT). The secondary objective was to analysis the incidence of Adverse Events (AEs) and efficacy. Results: As of Oct 31, 2020, 23 pts have been enrolled (Cohort A:14, Cohort B: 9; median age: 54 years; median prior therapies: 2 lines;). Cohort A was escalating at 600mg, and Cohort B was escalating at 400mg. Two pts experienced DLTs: one DLT (G4 hypercalcemia) was observed at 600mg in Cohort A; the other DLT (G3 rash) was observed at 400mg in Cohort B. MDT was not reached and the study was still ongoing. In Cohort A, ORR and DCR in evaluable pts were 21.4% (3/14, all confirmed) and 42.9% (6/14). Partial response was observed in 3 pts with liver cancer (1/3), renal cancer (1/3), and cervix cancer (1/3). In Cohort B, ORR and DCR in evaluable pts were 33.3%(3/9, all confirmed) and 77.8%(7/9). Partial response was observed in 3 pts with SCLC (1/3), prostate cancer (1/3) and renal cancer (1/3). The incidence of pts with TRAEs and grade>=3 TRAEs were 91.3% (21/23) and 39.1% (9/23) respectively. The most common grade>=3 TRAEs were hypercalcemia (26.1%, 6/23), fatigue (17.4%, 4/23) and nausea (13.0%, 3/23). No fatal AEs were observed. G3 nausea, G3 lipase increased and G2 GGT increased resulted in SHR9146 dose reduction in 3 pts (Cohort A). Conclusions: SHR9146 plus camrelizumab in combination with/without apatinib demonstrated promising anti-tumor activity with acceptable safety in pts with advanced solid tumors. Further study is needed to validate the efficacy and safety. Clinical trial information: NCT03491631.

scholarly journals ACTR-59. A PHASE 1 STUDY OF BPM31510 PLUS VITAMIN K IN SUBJECTS WITH HIGH-GRADE GLIOMA THAT HAS RECURRED ON A BEVACIZUMAB-CONTAINING REGIMEN

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi27-vi27
Author(s):  
Lawrence Recht ◽  
Reena Thomas ◽  
Sophie Bertrand ◽  
Priya Yerballa ◽  
Gordon Li ◽  
...  
Keyword(s):  
Phase I ◽  
Vitamin K ◽  
Phase I Study ◽  
Phase 1 ◽  
High Grade Glioma ◽  
High Grade ◽  
Open Label ◽  
Open Label Phase ◽  
Grade 3

Abstract BACKGROUND High-grade gliomas (HGG) are characterized by dysregulated metabolism, utilizing glycolysis for energy production to support unrestricted growth. BPM 31510, an ubidecarenone (coenzyme Q10) containing lipid nanodispersion, causes a switch in cancer energy sourcing from glycolysis towards mitochondrial oxidative phosphorylation in vitro, reversing the Warburg effect and suggesting potential as an anti-tumor agent. The current study is a phase I study of BPM31510 + vitamin K in GB with tumor growth after bevacizumab (BEV). METHODS This is an open-label phase I study of BPM31510 continuous infusion with weekly vitamin K (10mg IM) in HGG patients using an mTPI design, starting at 110mg/kg, allowing for a single dose de-escalation and 2 dose-escalations. Patients had received first-line ChemoRadiation and were in recurrence following a BEV containing regimen. RESULTS 9 eligible and evaluable patients completed the 28 day DLT period. 8 patients had primary GB, 1 had anaplastic astrocytoma with confirmed pathologic transformation to GB. Median age was 55 years (27–67) and median KPS 70 (60–90) at enrollment. 4 patients were treated at the highest dose 171mg/kg, where there was a single DLT: Grade 3 AST & ALT. The most common grade 1–2 AEs possibly, probably or definitely related to drug were elevated AST, rash, and fatigue, each occurring in 3 patients. Median OS for 9 eligible/evaluable patients was 128 days (95% CI: 48–209) while PFS was 34 days (CI of mean 8.9). 3 patients are currently alive; 2 patients have survived >1 year. PK/PD data are being processed and will be presented. CONCLUSION This study confirms that BPM 31510 + vitamin K is safe and feasible in treatment-refractory HGG patients. Though this study demonstrates safety at 171mg/kg, the proposed dose for future studies in GB, based on additional pre-clinical and non-GB clinical data is 88mg/kg.

Phase I study of docetaxel with concomitant thoracic radiation therapy.

1998 ◽  
Vol 16 (1) ◽  
pp. 159-164 ◽  
Author(s):  
A M Mauer ◽  
G A Masters ◽  
D J Haraf ◽  
P C Hoffman ◽  
S M Watson ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Study ◽  
Optimal Schedule ◽  
Late Toxicity ◽  
Maximum Tolerated Dose ◽  
Small Cell Lung ◽  
Weekly Administration ◽  
Thoracic Radiation ◽  
Radiation Sensitizers ◽  
Administration Schedules

PURPOSE The taxanes have demonstrated activity as radiation sensitizers in preclinical studies. This study was designed to determine the maximum-tolerated dose (MTD), optimal schedule, and toxicities of docetaxel in combination with concomitant standard chest radiotherapy. PATIENTS AND METHODS Twenty-nine patients with advanced non-small-cell lung or esophageal cancer enrolled in this phase I study to evaluate escalating docetaxel doses at three schedules. Docetaxel was administered as two 21-day cycles at doses of 40, 60, and 75 mg/m2 per cycle. Docetaxel administration schedules were as follows: schedule A, once every 3 weeks; schedule B, 2 of 3 weeks; or schedule C, weekly. Six weeks of concomitant standard chest radiotherapy in 1.8- to 2.0-Gy daily fractions was delivered to 60 Gy total. RESULTS Dose-limiting esophagitis and neutropenia were encountered with schedules A and B at docetaxel doses of 60 mg/m2 per cycle. The docetaxel MTD for schedules A and B was 40 mg/m2 per cycle. Dose-limiting esophagitis was also observed with schedule C; however, there was no neutropenia. For schedule C, we identified the MTD as 60 mg/m2 per cycle (20 mg/m2/wk). Other toxicities encountered included thrombocytopenia, hypersensitivity reaction, and pulmonary infiltrates (fatal in two patients). Late toxicity of esophageal stricture occurred in five patients. CONCLUSION Esophagitis and neutropenia are the dose-limiting toxicities of docetaxel administered with concomitant chest radiotherapy. Weekly administration of docetaxel allows for the highest total docetaxel dose during chest radiotherapy. We identified the recommended phase II docetaxel dose as 20 mg/m2 administered weekly with concomitant chest radiotherapy for 6 weeks.

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