A phase I/II study of divided-dose docetaxel, cisplatin, and fluorouracil (DCF) for patients with recurrent or metastatic squamous cell carcinoma of the esophagus.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 132-132
Author(s):  
Toshiyasu Ojima ◽  
Mikihito Nakamori ◽  
Masaki Nakamura ◽  
Makoto Iwahashi ◽  
Masahiro Katsuda ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Squamous Cell ◽  
Response Rate ◽  
Carcinoma Of The Esophagus ◽  
Metastatic Squamous Cell Carcinoma ◽  
Level 3 ◽  
Grade 3

132 Background: The aim of this phase I/II study was to evaluate the efficacy and safety of the combined use of docetaxel, cisplatin (CDDP) and 5-fluorouracil (5-FU) (DCF) in patients with recurrent/metastatic squamous cell carcinoma of the esophagus (SCCE). This study adopted divided doses of docetaxel and CDDP in order to reduce the toxicities of the treatment. Methods: The dose of docetaxel was escalated using the following protocol in the phase I stage: level 1, 30; level 2, 35 and level 3, 40 mg/m2, which was intravenously infused for two hours on days 1 and 8. CDDP was administered at a dose of 12 mg/m2 infused for four hours on days 1-5. The 5-FU was administered at a dose of 600 mg/m2continuously infused from day 1 to 5. This regimen was repeated every four weeks. Results: The study subjects were nine patients (phase I) and 48 patients (phase II). The recommended dose was determined as level 3 in phase I. In the phase II stage, the overall response rate was 62.5%, with a complete response rate of 12.5%. The median progression-free survival was six months, and the median overall survival was 13 months. Grade 3/4 toxicities of leukopenia, neutropenia and febrile neutropenia occurred in 64.6, 68.8 and 14.6% of the patients, while grade 3/4 non-hematological toxicities were relatively rare. No treatment-related death was recorded. Conclusions: This modified DCF regimen can be a tolerable definitive chemotherapy for unresectable SCCE because of its high efficacy, although adequate care for severe neutropenia is needed. Clinical trial information: NCT00915850.

Phase II trial of irinotecan and cisplatin combination as first-line chemotherapy in patients with advanced esophageal squamous-cell carcinoma: An interim report.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 137-137
Author(s):  
X. Zhang ◽  
L. Shen ◽  
J. Li ◽  
Y. Li ◽  
J. Zhou ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Response Rate ◽  
Objective Response ◽  
Complete Response ◽  
Carcinoma Of The Esophagus ◽  
Metastatic Squamous Cell Carcinoma ◽  
Grade 3

137 Background: Although the irinotecan and cisplatin combination has been used in esophageal cancer treatment, we tested the combination specifically in unresectable or metastatic esophageal squamous cell carcinoma with different doses to decrease the toxicity and keep the efficacy. Methods: Patients were eligible if they had histologic proof of unresectable or metastatic squamous cell carcinoma of the esophagus, between 18-75 years of age with a Karnofsky performance status ≥ 80. No prior chemotherapy was allowed. Patients were treated with irinotecan 130 mg/m2 and cisplatin 60 mg/m2 repeated 3 weeks. Response was evaluated every two cycles of treatment by using RECIST criteria. The sample size was calculated using Simon's 2-stage design. The primary end point of the study was objective response rate. The second end points are PFS and toxicity. Accrual was planned to a total of 46 patients with the targeted response rate of 50%. The first stage requires at least 7 or more out of 16 patients to have a confirmed partial or complete response before proceeding to the second stage. Results: Twenty one patients have been enrolled so far, of which 16 patients were assessable for response. The overall response rate was 43.8%(7/16), including one complete response (6.3%) and six partial response (37.5%). Among 13 patients who presented with dysphagia at baseline, 10 (62.5%) had the symptom either completely resolved or significantly improved. The most common toxicities were neutropenia, diarrhea and alopecia. Seven patients (33.3%) developed grade 3 neutropenia and one had (4.8%) with febrile neutropenia. One patient (4.8%) had grade 3 diarrhea. There were no treatment-related deaths. Conclusions: The combination of irinotecan plus cisplatin with lower doses showed equivalent efficacy and less toxicity in patients with unresectable or metastatic squamous-cell carcinoma of the esophagus. The study is ongoing. No significant financial relationships to disclose.

Cetuximab, paclitaxel, cisplatin and concurrent radiation in Chinese patients with locally advanced esophageal squamous cell carcinoma: An open-label, multicenter, phase II study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4073-4073
Author(s):  
Jinming Yu ◽  
Xue Meng ◽  
Jian hua Wang ◽  
Xindong Sun ◽  
Lv hua Wang ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Squamous Cell ◽  
Response Rate ◽  
Locally Advanced ◽  
Chinese Patients ◽  
Open Label ◽  
Grade 3

4073 Background: In China more than 90% of esophageal malignancies are of squamous cell carcinoma (SCC). We conducted this Chinese multicenter trial to determine the efficacy and safety of the addition of cetuximab with paclitaxel, cisplatin, and concurrent radiation for patients with esophageal SCC and to determine whether KRAS status predicts response. Methods: Patients with unresectable locally advanced cervical, upper or mid-esophageal SCC without distant metastasis were eligible for this open-label phase II trial. All patients received cetuximab (400 mg/m2 day 1 before chemoradiotherapy and 250 mg/m2 q1w × 7 weeks), paclitaxel (45 mg/m2 q1w × 7 weeks) and cisplatin (20 mg/m2 q1w × 7 weeks) with 59.4 Gy of radiation. The primary end point was response rate. Second end points included toxicity, overall survival (OS), progression-free survival (PFS), and KRAS mutation status. Results: Fifty-five patients were enrolled and evaluable to safety. Non-hematological adverse events were generally grade 1 or 2, and were most often rash (94.5%), mucositis (58.2%), fatigue (45.5%), nausea (41.8%) and hepatic dyfunction (40%). Hematologic adverse events included grade 3 neutropenia (32.7%) and grade 3 anemia (1.82%). Ten patients did not complete the protocol therapy (6 for chemotherapy dose delays, 1 for paciltaxel hypersensitivity, 1 by the treating physicians for unstated reasons, 1 for concurrent unrelated infection, and 1 for tracheo-esophageal fistula). The response rate was 97.7%. The 1-year OS and median OS was 87.3% and 16.8 months, the 1-year PFS and median PFS was 30.4% and 13.9 months, respectively. No mutations were detected at KRAS codons 12 or 13 in the 52 available specimens. Conclusions: Cetuximab can be safely administered with chemoradiation for Chinese patients with esophageal cancer and may improve the clinical response rate. KRAS mutations were too rare to be analyzed as a predictor of response.

Phase II study of single-agent etoposide in patients with metastatic squamous-cell carcinoma of the esophagus

1992 ◽  
Vol 29 (4) ◽  
pp. 321-322 ◽  
Author(s):  
Andreas Harstrick ◽  
Carsten Bokemeyer ◽  
Peter Preusser ◽  
Claus Henning K�hne-W�mpner ◽  
Hans-Joachim Meyer ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Squamous Cell ◽  
Phase Ii Study ◽  
Single Agent ◽  
Carcinoma Of The Esophagus ◽  
Metastatic Squamous Cell Carcinoma

Phase I/II Trial of Erlotinib and Cisplatin in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: A Princess Margaret Hospital Phase II Consortium and National Cancer Institute of Canada Clinical Trials Group Study

2007 ◽  
Vol 25 (16) ◽  
pp. 2178-2183 ◽  
Author(s):  
Lillian L. Siu ◽  
Denis Soulieres ◽  
Eric X. Chen ◽  
Gregory R. Pond ◽  
Soo F. Chin ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Phase Ii ◽  
Squamous Cell ◽  
Objective Response Rate ◽  
Response Rate ◽  
Kinase Inhibitor ◽  
Objective Response ◽  
Metastatic Squamous Cell Carcinoma

Purpose To determine the phase II dose and objective response rate of erlotinib, a selective epidermal growth factor receptor tyrosine kinase inhibitor, in combination with cisplatin in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC). Patients and Methods HNSCC patients with no prior chemotherapy and measurable disease were treated in three escalating-dose cohorts of daily continuous oral (PO) erlotinib and intermittent intravenous (IV) cisplatin given every 21 days. The recommended phase II dose (RPTD) was then evaluated in a two-stage trial with a primary end point of objective response rate. Results A total of 51 patients were enrolled. The RPTD was identified as erlotinib 100 mg PO daily and cisplatin 75 mg/m2 IV every 21 days. Forty-five patients were treated at the RPTD, of which 44 and 43 were eligible for toxicity and efficacy evaluations, respectively. The intention-to-treat response rate was 21%, with one complete and eight partial responses (95% CI, 10% to 36%), and disease stabilization was achieved in 21 patients (49%; 95% CI, 33% to 65%). Median progression-free survival was 3.3 months (95% CI, 2.7 to 4.8 months) and median overall survival was 7.9 (95% CI, 5.6 to 9.5) months. The combination was well tolerated, with minimal grade 3 or higher toxicity. Subgroup analysis suggested that patients who developed higher grade skin rashes during cycle 1 had better survival outcomes (P = .034). Conclusion This schedule of erlotinib and cisplatin has a favorable toxicity profile and has antitumor activity in HNSCC comparable to standard combination chemotherapy regimens.

Phase I/II Study of Cetuximab in Combination With Cisplatin or Carboplatin and Fluorouracil in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

2006 ◽  
Vol 24 (18) ◽  
pp. 2866-2872 ◽  
Author(s):  
Jean Bourhis ◽  
Fernando Rivera ◽  
Ricard Mesia ◽  
Ahmad Awada ◽  
Lionel Geoffrois ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Area Under The Curve ◽  
Clear Trend ◽  
Metastatic Squamous Cell Carcinoma ◽  
Two Phases ◽  
Grade 3

Purpose This was an open, randomized, multicenter, phase I/II study to investigate the safety and tolerability of cetuximab in the first-line treatment of recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN). Patients and Methods Treatment comprised cetuximab (initial dose 400 mg/m2 with subsequent weekly doses of 250 mg/m2) in combination with 3-week cycles of either cisplatin (100 mg/m2) or carboplatin (area under the curve, 5), each in combination with a 5-day infusion of fluorouracil (FU) at escalating doses of 600, 800, and 1,000 mg/m2/d. The study was divided into two phases: A, the first two cycles (6 weeks) focusing on the safety and tolerability of combination therapy; and B, the remaining time for those benefiting from therapy until disease progression or intolerable toxicity. Results Fifty-three patients were enrolled onto the study. The incidence of dose-limiting toxicities in phase A was acceptable. The most common grade 3/4 adverse events in both groups were leucopenia (38%), asthenia (25%), vomiting (14%), and thrombocytopenia (15%), which are consistent with the known safety profiles of cetuximab, cisplatin/carboplatin, and FU. The overall response rate among patients was 36%, with no clear trend toward an increased efficacy at the highest dose of FU, and no impact of the concomitant chemotherapy regimens on cetuximab pharmacokinetics. Conclusion The combination of cetuximab, cisplatin/carboplatin, and FU was reasonably well tolerated and active in recurrent/metastatic SCCHN, and merits additional investigation. An FU dose of 1,000 mg/m2/d in combination with cisplatin or carboplatin can be recommended for additional studies.

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