Soblidotin and Gemcitabine 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 soblidotin and gemcitabine, 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 soblidotin and gemcitabine in treating patients with locally advanced or metastatic solid tumors.

Detailed Description
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OBJECTIVES: Primary Determine the maximum tolerated dose of soblidotin and gemcitabine in patients with locally advanced or metastatic solid tumors. Determine the dose-limiting toxic effects of this regimen in these patients. Secondary Determine the toxicity profile of this regimen in these patients. Determine the pharmacokinetics of this regimen in these patients. Determine, preliminarily, the antitumor activity of this regimen in these patients. OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study. Patients receive gemcitabine IV over 30 minutes and soblidotin IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of soblidotin and gemcitabine 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. Patients are followed for survival every 3 months after completion of study therapy. PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study within 1 year.

Official Title
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Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: gemcitabine
* Drug: soblidotin
* Procedure: chemotherapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced or metastatic solid tumors Minimally pretreated Not refractory to prior gemcitabine therapy No disease progression during initial treatment with gemcitabine No symptomatic brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases are present) Renal Creatinine no greater than 1.5 times ULN Cardiovascular Ejection fraction at least 40% by MUGA Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No psychiatric disorder that would preclude study consent or compliance No concurrent severe or uncontrolled underlying medical disease unrelated to the tumor that would compromise patient safety or affect study outcome No hypersensitivity to gemcitabine No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless in complete remission and off all therapy for that disease for at least 2 years No serious infection No grade 2 or greater neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent anticancer biologic therapy Chemotherapy See Disease Characteristics Recovered from prior chemotherapy No other concurrent anticancer chemotherapy Endocrine therapy Not specified Radiotherapy Recovered from prior radiotherapy No concurrent anticancer radiotherapy Concurrent localized palliative radiotherapy to a non-indicator lesion for pain control allowed only if other methods of pain control are ineffective Surgery At least 4 weeks since prior major surgery and recovered Other More than 28 days since prior investigational drugs, including analgesics or antiemetics At least 4 weeks since prior myelosuppressive therapy 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine|nan|
|Drug: soblidotin|nan|
|Procedure: chemotherapy|nan|

What is the study measuring?
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Primary Outcome Measures

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