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DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma



DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma

For Condition: Colon Cancer,Rectal Cancer
Status: Recruiting
Sponsor(s): Daiichi Pharmaceuticals ,
Synopsis: 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: Phase II trial to study the effectiveness of DJ-927 as second-line therapy in treating patients who have progressivelocally advanced or metastaticcolorectaladenocarcinoma (cancer).
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RobertDeJager,  Study Chair,  Daiichi Pharmaceuticals

University of Texas - MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030-4009
United States
Recruiting Paulo  Hoff 713-792-2828


Additional Information:
Study ID Numbers:  CDR0000356034;  MDA-2003-0749,DAIICHI-927A-PRT004
Study Start Date: 
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080834

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