Ro 31-7453 in Treating Patients With Recurrent or Refractory Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Phase II Study of Two Shcedules of Ro 31-7453 in Patients With Metastatic (Dukes' D) Colorectal Carcinoma (CRC) Who Have Failed Both Fluoropyrimidine and Irinotecan Chemotherapy

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: MKC-1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MKC-1|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum