ECOG 1297: a phase I study of preoperative radiation therapy (RT) with concurrent protracted continuous infusion 5-FU and dose escalating oxaliplatin followed by surgery, adjuvant 5-FU, and leucovorin for locally advanced (T3/4) rectal adenocarcinoma

2003 ◽  
Vol 57 (2) ◽  
pp. S179 ◽  
Author(s):  
J.C Landry ◽  
D Rosenthal ◽  
F Spitz ◽  
D Haller ◽  
A Benson ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Phase I ◽  
Continuous Infusion ◽  
Phase I Study ◽  
Locally Advanced ◽  
Rectal Adenocarcinoma ◽  
Preoperative Radiation ◽  
Preoperative Radiation Therapy ◽  
Dose Escalating

scholarly journals Phase I study of pre-operative continuous 5-FU and sorafenib with external radiation therapy in locally advanced rectal adenocarcinoma

2016 ◽  
Vol 118 (2) ◽  
pp. 382-386 ◽  
Author(s):  
Richard Kim ◽  
Gopi Kesaria Prithviraj ◽  
Ravi Shridhar ◽  
Sarah E. Hoffe ◽  
Kun Jiang ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Phase I ◽  
Phase I Study ◽  
Locally Advanced ◽  
Rectal Adenocarcinoma ◽  
External Radiation ◽  
External Radiation Therapy

Phase I study of preoperative continuous 5-FU and sorafenib with external radiation therapy in locally advanced rectal adenocarcinoma.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 3636-3636
Author(s):  
Gopi Kesaria Prithviraj ◽  
Kun Jiang ◽  
Xiuhua Zhao ◽  
Dung-Tsa Chen ◽  
Brian Morse ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Phase I ◽  
Phase I Study ◽  
Locally Advanced ◽  
Rectal Adenocarcinoma ◽  
External Radiation ◽  
External Radiation Therapy

Phase I study of preoperative capecitabine and lenvatinib with external radiation therapy in locally advanced rectal adenocarcinoma.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 694-694
Author(s):  
Jessica Frakes ◽  
Rutika Mehta ◽  
Sarah E. Hoffe ◽  
Iman Imanirad ◽  
Maria E Martinez Jimenez ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Rectal Cancer ◽  
Radiation Therapy ◽  
Phase I ◽  
Phase I Study ◽  
Locally Advanced ◽  
Vascular Endothelial Cell ◽  
Rectal Adenocarcinoma ◽  
External Beam Radiation ◽  
Beam Radiation

694 Background: Despite routine use of neoadjuvant chemoradiation, patients with advanced rectal tumors experience significant rates of treatment failure and recurrence. Radiation resistance is a particular problem. Dual targeting of PDGF and VEGFR (Vascular endothelial cell growth factor receptor) in combination with radiation can enhance tumor response. Lenvatinib inhibits the kinase activities of VEGFR1-3, FGFR1-4, PDGFRα, KIT, and RET and in vivo results show that it effectively delays the growth of human colorectal xenografts. Methods: This is a phase I clinical trial of lenvatinib in combination with capecitabine administered with radiation. Patients with stage II or III rectal cancer confirmed by endoscopic ultrasound or MRI were eligible for the study. In this 3+3 phase I study with 3 cohorts, patients were treated with escalating doses of lenvatinib administered in combination with standard doses of capecitabine (850 mg/m2 PO BID D1-5 weekly for 5 ½ to 6 weeks) and external beam radiation therapy (180 cGY on D1-5 weekly for 5 ½ to 6 weeks). Patients underwent surgery 6-10 weeks after neoadjuvant therapy. Results: Nine patients have been enrolled in the 3 cohorts with the median age of 51 years. Lenvatinib dosing started at 14 mg PO daily (cohort 1) and was safely escalated to 20 mg PO daily (cohort 2) followed by 24 mg PO daily (cohort 3). There were no DLTs at the maximum tested dose of lenvantinib (24 mg). 5 patients have undergone low anterior resection and 4 have had abdominoperineal resection. The pathological complete response (pCR) rate was 33.33%, and downstaging was observed in 100% of patients. Median neoadjuvant rectal cancer score (NAR) was 8.7. Three pts had grade 3 events (2 hypertension (HTN), 1 lymphopenia) without any grade 4 events. Most common AEs were HTN and fatigue. No perioperative complications were observed. Tissues for all pts have been collected for planned correlative studies. Conclusions: This study shows that the combination of lenvatinib with capecitabine, and EBRT is well tolerated. NAR score and downstaging rates are encouraging. Currently we are enrolling 10 additional pts at the maximum tested dose of lenvatinib to further evaluate efficacy and safety. Clinical trial information: NCT02935309.

Phase I/II Study of Preoperative Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy in Patients With Locally Advanced Rectal Cancer: Cancer and Leukemia Group B 89901

2006 ◽  
Vol 24 (16) ◽  
pp. 2557-2562 ◽  
Author(s):  
David P. Ryan ◽  
Donna Niedzwiecki ◽  
Donna Hollis ◽  
Brent E. Mediema ◽  
Scott Wadler ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Phase I ◽  
Continuous Infusion ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Rectal Adenocarcinoma ◽  
External Beam Radiation ◽  
Beam Radiation ◽  
Grade 3 ◽  
Experienced Grade

Purpose The addition of oxaliplatin to fluorouracil in patients with advanced colorectal cancer improves survival. This phase I/II study evaluated the addition of weekly oxaliplatin to preoperative continuous infusion fluorouracil (FU) and external-beam radiation therapy (RT) in patients with locally advanced rectal adenocarcinoma. Patients and Methods Patients with clinical T3/T4 rectal adenocarcinoma and no evidence of metastases were treated with weekly oxaliplatin, continuous infusion FU 200 mg/m2 intravenously, and RT. A total of 6 weekly doses of oxaliplatin were planned. RT dose was 1.8 Gy/fraction to a total dose of 50.4 Gy. In the phase I portion, oxaliplatin was escalated from 30 to 60 mg/m2. Results Forty-four patients were entered onto the study, 18 on the phase I portion and 26 on the phase II portion. The maximum-tolerated dose (MTD) for oxaliplatin was determined to be 60 mg/m2. At the MTD, 12 patients experienced grade 3 or 4 diarrhea, two patients experienced grade 3 neutropenia, and one patient experienced grade 3 thrombocytopenia. Fifty-six percent of patients entered at the MTD completed all 6 weeks of oxaliplatin. Eight (25%) of 32 patients enrolled at the phase II dose experienced a pathologic complete response. Conclusion In this multicenter study, the addition of oxaliplatin to intravenous continuous infusion FU and RT for patients with locally advanced rectal cancer was associated with a high pathologic complete response rate but more toxicity than when FU is used alone. A regimen of weekly oxaliplatin, continuous infusion FU, and radiation therapy is now being evaluated by the National Surgical Adjuvant Breast and Bowel Project.

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