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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: DJ-927


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DJ-927|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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