Colon Cancer Clinical Trial
DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma
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).
Full 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.
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
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There are 2 Locations for this study
Albuquerque New Mexico, 87131, United States
Houston Texas, 77030, United States
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