Adenocarcinoma of the Rectum Clinical Trial
Official title:
A Phase I/II Study of Preoperative Oxaliplatin (NSC# 266046), 5-Fluorouracil, and External Beam Radiation Therapy in Locally Advanced Rectal Cancer
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may be a more effective treatment for cancer of the rectum. Phase II trial to study the effectiveness of combining oxaliplatin, fluorouracil, and external-beam radiation therapy followed by surgery in treating patients who have locally advanced cancer of the rectum
Status | Completed |
Enrollment | 24 |
Est. completion date | |
Est. primary completion date | October 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically proven previously untreated adenocarcinoma of the rectum thatbegins within 12 cm of the anal verge by sigmoidoscopy and/or colonoscopy - Locally advanced disease defined as any of the following: - Fixed or immovable tumor on physical exam - T4 disease with invasion of adjacent structures (e.g., pelvic sidewall, sacral pelvis, bladder, or prostate) by CT scan, rectal ultrasound, or MRI - T3 disease with invasion through the wall of the muscularis propria by transrectal ultrasound, CT scan, or MRI - No distant metastatic disease - Performance status - ECOG 0-2 - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Bilirubin no greater than upper limit of normal (ULN) - SGOT/SGPT no greater than 2.5 times ULN - Creatinine no greater than 1.5 mg/dL - Creatinine clearance at least 60 mL/min - No active second malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix - Patients are not considered to have an active second malignancy if they have completed therapy and are at less than 30% risk of relapse - No prior or concurrent evidence of neuropathy - No history of allergy to platinum compounds or antiemetics - Not pregnant or nursing - Fertile patients must use effective contraception - No prior fluorouracil or platinum-based therapy for any malignancy - No other concurrent chemotherapy - Hormonal therapy allowed only for non-disease related conditions (e.g., insulin for diabetes) OR intermittently as an antiemetic (e.g., dexamethasone) - No prior pelvic irradiation - No concurrent antiretroviral therapy (HAART) for HIV positive patients |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cancer and Leukemia Group B | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The maximum tolerated dose of oxaliplatin when delivered concurrently with 5-FU and external beam radiation in patients with locally advanced rectal adenocarcinomas | 7 days | Yes | |
Primary | Progression-free survival | Will be estimated using the Kaplan-Meier method. | From protocol entry until documented progression of disease or death from any cause, assessed up to 5 years | No |
Primary | Pathological complete response rate | The new regimen will be considered worthy of further investigation if 5 or greater CR's are observed among the 25 patients treated at the MTD. Assuming the new regimen will result in a 30% CR rate, the probability of observing 5 or greater CR's in 25 patients studied is 0.91. For an underlying CR rate of 0.25 this probability is 0.79. The probability of observing 5 or greater CR's if the underlying CR rate is 0.10 is 0.10. | Up to 5 years | No |
Primary | Latent toxicities graded using the Common Toxicity Criteria (CTC) version 2.0 | Up to 5 years | Yes |
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