Colorectal Cancer
Conditions
Keywords
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
Brief summary
RATIONALE: Drugs used in chemotherapy, such as DJ-927, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well DJ-927 works as second-line therapy in treating patients with progressive locally advanced or metastatic colorectal adenocarcinoma (cancer).
Detailed description
OBJECTIVES: Primary * Determine the objective tumor response rate in patients with progressive locally advanced or metastatic adenocarcinoma of the colon or rectum treated with DJ-927 as second-line treatment. Secondary * Determine the duration of response in patients treated with this drug. * Determine the time to tumor progression in patients treated with this drug. * Determine the median survival time in patients treated with this drug. * Determine the quantitative and qualitative toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior first-line treatment regimen (irinotecan-containing vs oxaliplatin-containing). Patients receive oral DJ-927\* on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. NOTE: \*Patients receive 1 of 2 selected doses to confirm the previously established maximum tolerated dose Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 56-62 patients (28-31 per stratum) will be accrued for this study within 12 months.
Interventions
DRUGDJ-927
Sponsors
Daiichi Sankyo
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed