A Phase II Study Of Oral DJ-927 Administered As A Single Dose Every Three Weeks To Patients With Advanced Or Metastatic Adenocarcinoma Of The Colon Or Rectum

Date de début de l'étude : 1 février 2004

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