NCT00016250CompletedPhase 2
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
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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:
- •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
- •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)
- •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
- •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
- •No prior total gastrectomy
- +1 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
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