Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00016250


Primary Contact:

Study Chair
Sunil Sharma, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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