Paclitaxel and ABI-007 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 paclitaxel and ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining paclitaxel with ABI-007 may kill more tumor cells. PURPOSE: Randomized phase I trial to study the effectiveness of combining paclitaxel with ABI-007 in treating patients who have locally advanced or metastatic solid tumors.

Detailed Description
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OBJECTIVES: Primary Determine whether a change in the formulation alters the pharmacokinetic profile of paclitaxel in the plasma of patients with incurable locally advanced or metastatic solid tumors treated with ABI-007 and paclitaxel. Secondary Correlate pharmacokinetic data of this regimen with decrease in the neutrophil count at nadir in these patients. Determine the intra- and interindividual pharmacokinetic variability of ABI-007 in these patients. Determine protein binding of paclitaxel via measurement of α-1-acid glycoprotein and serum albumin levels in patients treated with this regimen. OUTLINE: This is a randomized, pilot study. Courses 1 and 2: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1 and ABI-007 IV over 30 minutes on day 22. Arm II: Patients receive ABI-007 IV over 30 minutes on day 1 and paclitaxel IV over 3 hours on day 22. Courses 3 and beyond: All patients receive ABI-007 IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Official Title
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Randomized, Crossover, Pharmacokinetic Study Of Paclitaxel (Taxol) And ABI-007 (A Cremophor EL-Free, Protein Stabilized, Nanoparticle Paclitaxel) In Patients With Advanced Solid Tumors

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: paclitaxel
* Drug: paclitaxel albumin-stabilized nanoparticle formulation


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor Considered incurable Locally advanced or metastatic disease Likely to be responsive to taxane-based therapy Patients who are refractory to prior paclitaxel are ineligible No symptomatic or untreated brain metastasis or carcinomatous meningitis No patients who are unable to remain free of corticosteroid therapy for > 4 weeks due to CNS disease No previously untreated locally advanced breast cancer No hematologic malignancy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic Granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal ALT and AST ≤ 1.5 times upper limit of normal Renal Creatinine normal OR Creatinine clearance ≥ 60 mL/min Cardiovascular LVEF ≥ 40% No clinical signs or symptoms of heart failure No symptomatic congestive heart failure No unstable angina pectoris Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 months after study participation No history of allergic reaction attributed to compounds of similar chemical or biologic composition to paclitaxel (e.g., docetaxel, Cremophor^® EL [CrEL], polysorbate 80 [Tween 80], or CrEL-containing medications [e.g., cyclosporine]) No history of seizure disorder requiring anticonvulsant therapy No active serious infection No psychiatric illness or social situation that would preclude study compliance No other uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy No concurrent filgrastim (G-CSF) during courses 1 and 2 Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No other concurrent chemotherapy Endocrine therapy See Disease Characteristics At least 2 weeks since prior hormonal therapy Concurrent luteinizing hormone-releasing hormone agonists for prostate cancer allowed Radiotherapy At least 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery Not specified Other More than 2 weeks since prior drugs, herbal preparations, or dietary supplements known to influence CYP3A4 (e.g., phenytoin, rifampin, Hypericum perforatum [St. John's wort], garlic supplements, or grapefruit juice) and/or CYP2C8 No concurrent substances known or likely to interfere with the pharmacokinetics of paclitaxel (e.g., verapamil or cyclosporine) No other concurrent investigational agents No other concurrent anticancer 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: paclitaxel|nan|
|Drug: paclitaxel albumin-stabilized nanoparticle formulation|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