Colorectal Cancer
Conditions
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of Ro 31-7453 in treating patients who have recurrent or refractory metastatic colorectal cancer.
Detailed description
OBJECTIVES: * Compare the objective disease rate of patients with recurrent or refractory metastatic colorectal cancer treated with two dose schedules of Ro 31-7453. * Compare the safety and tolerability of these regimens in these patients. * Compare the response duration in patients treated with these regimens. * Compare the time to progression and time to treatment failure in patients treated with these regimens. * Determine the pharmacokinetic profiles of Ro 31-7453 and its major metabolites in these patients. * Compare the overall survival of patients treated with these regimens. OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one of two treatment arms. * Arm I: Patients receive oral Ro 31-7453 twice daily on days 1-4. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive oral Ro 31-7453 twice daily on days 1-14. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 28 days and then every 3 months. PROJECTED ACCRUAL: Approximately 160 patients (49 per treatment arm plus 61 additional patients in the arm determined to be most effective) will be accrued for this study within 1 year.
Interventions
DRUGMKC-1
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic adenocarcinoma of the colon or rectum * Bidimensionally measurable disease * At least 2.0 x 2.0 cm * Failed prior fluoropyrimidine and irinotecan chemotherapy in adjuvant or metastatic setting * Must have had disease progression while receiving chemotherapy OR * If received fluorouracil with or without irinotecan in adjuvant setting, must also have failed therapy with these agents in metastatic setting (unless manifesting metastatic disease during adjuvant therapy) * No known CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * Hemoglobin at least 9 g/dL * Absolute neutrophil count at least 1,500/mm\^3 * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present) * Alkaline phosphatase no greater than 2.5 ULN (5 times ULN if bone or liver metastases present) Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No New York Heart Association class III or IV congestive heart failure * No myocardial infarction within the past 6 months Gastrointestinal: * No bowel obstruction * No active uncontrolled malabsorption syndrome Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection * No other prior malignancy within the past 5 years except carcinoma in situ of the cervix or non-melanoma skin cancer * No other active cancers, including stable disease on adjuvant therapy * No other medical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * See Chemotherapy * At least 2 weeks since prior biologic therapy and recovered Chemotherapy: * See Disease Characteristics * No more than 2 prior cytotoxic chemotherapy regimens for metastatic disease * Monoclonal antibody (MOAB) therapy and antiangiogenic agents not included as prior cytotoxic chemotherapy * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: * Not specified Radiotherapy: * At least 3 weeks since prior radiotherapy and recovered Surgery: * No prior total gastrectomy Other: * No other concurrent investigational agents
Countries
United States
Outcome results
None listed