Phase I Study Of Tocladesine In Patients With Colorectal Carcinoma Following Therapy With 5-FU And Irinotecan
18 Years
75 Years
Both
Colorectal Cancer
Trial Information
Phase I Study Of Tocladesine In Patients With Colorectal Carcinoma Following Therapy With 5-FU And Irinotecan
OBJECTIVES:
- Determine the maximum tolerated dose of tocladesine in patients with recurrent or
progressive metastatic colorectal cancer.
- Determine the qualitative and quantitative toxicity of this drug in these patients.
- Assess any therapeutic activity in patients treated with this drug.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive tocladesine IV continuously on days 1-5 and 8-12. Treatment repeats every
21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tocladesine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity. Once the MTD is determined, up to 14 additional
patients are treated at this dose level.
PROJECTED ACCRUAL: A total of 3-38 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of metastatic carcinoma of the colon or rectum
- Recurrent or progressive after failing prior fluorouracil and irinotecan
chemotherapy, sequentially or in combination, unless unable to tolerate
irinotecan
- Measurable disease
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST and ALT no greater than 5 times ULN
- PT/aPTT no greater than 1.2 times ULN
Renal:
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 50 mL/min
- No impaired renal function
Cardiovascular:
- No impaired cardiac function
Other:
- No active infection
- No other malignancy within the past 5 years except basal cell or squamous cell skin
cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- Not specified
Other:
- No other concurrent anticancer drugs
- No concurrent chronic non-steroidal anti-inflammatory agents
- No concurrent chronic therapeutic anticoagulation
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Lee S. Rosen, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068764
NCT ID:
NCT00021268
Start Date:
April 2001
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage IV colon cancer
- stage IV rectal cancer
- recurrent colon cancer
- recurrent rectal cancer
- Colorectal Neoplasms
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
