DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent colon cancer, recurrent rectal cancer, stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum Progressive locally advanced or metastatic disease Received 1 prior irinotecan- or oxaliplatin-containing regimen At least 1 measurable lesion Target lesion must be outside field of prior radiotherapy No symptomatic brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic ALT and AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Bilirubin ≤ 1.5 times ULN Renal Creatinine ≤ 1.5 times ULN Gastrointestinal No difficulty with swallowing No malabsorption No diarrhea (excess of 2-3 stools/day above normal frequency) within the past month No history of chronic diarrhea Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No concurrent serious infection No other concurrent severe or uncontrolled underlying medical condition that would preclude study participation No neuropathy ≥ grade 2 No history of any severe or life-threatening hypersensitivity reaction No psychiatric disorder that would preclude study compliance No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent biologic therapy Chemotherapy See Disease Characteristics At least 4 weeks since prior myelosuppressive chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Localized radiotherapy to non-indicator lesions for pain relief allowed provided other methods of pain control are ineffective Surgery At least 4 weeks since prior major surgery and recovered No prior major surgery in the stomach or small intestine Other More than 28 days since prior investigational agents (including analgesics and/or antiemetics) No other concurrent anticancer therapy No other concurrent cytotoxic therapy No concurrent grapefruit products
Sites / Locations
- University of New Mexico Cancer Research and Treatment Center
- MD Anderson Cancer Center at University of Texas