DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as DJ-927 and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of DJ-927 and capecitabine in treating patients with locally advanced or metastatic solid tumors.

Detailed Description
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OBJECTIVES: Primary Determine the maximum tolerated dose of DJ-927 and capecitabine in patients with locally advanced or metastatic solid tumors. Determine the dose-limiting and non-dose-limiting toxic effects of this regimen in these patients. Secondary Determine the toxicity profile of this regimen in these patients. Determine the possible pharmacokinetic interactions of this regimen in these patients. Determine the antitumor activity of this regimen in these patients. OUTLINE: This is an open-label, dose-escalation, nonrandomized, multicenter study. Course 1: Patients receive oral DJ-927 once on day 1 and oral capecitabine once on days 0 and 1 and twice daily on days 2-14. Course 2: Patients receive DJ-927 as in course 1 and oral capecitabine twice daily on days 2-15. Course 3 and all subsequent courses: Patients receive DJ-927 as in course 1 and oral capecitabine twice daily on days 1-14. All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of DJ-927 and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A minimum of 6 patients receive treatment at the MTD. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study within 18 months.

Official Title
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A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: DJ-927
* Drug: capecitabine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor Locally advanced or metastatic disease Minimally pretreated 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 at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Bilirubin no greater than 1.5 times ULN Renal Creatinine no greater than 1.5 times ULN Gastrointestinal No prior chronic diarrhea No swallowing and/or malabsorption problems No diarrhea (excess of 2-3 stools/day above normal frequency in the past month) Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No prior severe or life-threatening hypersensitivity reaction to a taxane or capecitabine No concurrent serious infection No neuropathy grade 2 or greater No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No other severe or uncontrolled underlying medical disease that would preclude study participation No psychiatric disorder that would preclude giving informed consent or study compliance PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent anticancer biologic therapy Chemotherapy Recovered from prior chemotherapy No other concurrent anticancer chemotherapy Endocrine therapy Not specified Radiotherapy Recovered from prior radiotherapy No concurrent anticancer radiotherapy Concurrent localized radiotherapy to a non-indicator lesion for pain relief is 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 At least 4 weeks since prior myelosuppressive therapy More than 28 days since prior investigational drugs (including analgesics and/or antiemetics) No other concurrent anticancer therapy No other concurrent anticancer cytotoxic therapy

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|
|Drug: capecitabine|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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unspecified adult solid tumor, protocol specific