- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00016250
Ro 31-7453 in Treating Patients With Recurrent or Refractory Metastatic Colorectal Cancer
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
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 Overview
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00-139
- CDR0000068613 (Registry Identifier: PDQ (Physician Data Query))
- ROCHE-16113
- ROCHE-RO31-7453
- NCI-G01-1945
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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