Status:
COMPLETED
DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma
Lead Sponsor:
Daiichi Sankyo
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 w...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00080834
Start Date
February 1 2004
End Date
August 1 2006
Last Update
May 16 2012
Active Locations (2)
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1
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-5636
2
MD Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009