Olimersen and Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed unresectable metastatic or recurrent adenocarcinoma of the colon or rectum No brain metastases unless previously treated, asymptomatic, on stable dose of decadron, and CT/MRI scan demonstrates no evidence of edema Phase I: Measurable or evaluable disease Phase II: Measurable disease Evidence of +1 bcl-2 expression on immunohistochemical staining in pathologic material PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Absolute granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases) PT/PTT normal Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection No serious concurrent systemic disorders that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered No other concurrent chemotherapy Phase I: At least 4 weeks since prior irinotecan and recovered Phase II: No more than 2 prior fluorouracil-based regimens for metastatic disease No prior irinotecan Endocrine therapy: See Disease Characteristics No concurrent anticancer hormonal therapy Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics Other: No other concurrent experimental medications
Sites / Locations
- Ireland Cancer Center
- Brooke Army Medical Center
- San Antonio Cancer Institute