Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

NIH - Warren Grant Magnuson Clinical Center

William D. Figg

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00095914
Information obtained from ClinicalTrials.gov on November 20, 2012

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