Paclitaxel and ABI-007 in Treating Patients With Locally Advanced or Metastatic Solid Tumors

NCT ID: NCT00095914

Last Updated: 2012-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2009-03-31

Brief 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.

Detailed Description

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

paclitaxel

Intervention Type: DRUG

paclitaxel albumin-stabilized nanoparticle formulation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Principal Investigators

William D. Figg, PharmD

Role: STUDY_CHAIR

National Cancer Institute (NCI)

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

04-C-0280

Identifier Type: -

Identifier Source: secondary_id

ABI-CA019

Identifier Type: -

Identifier Source: secondary_id

CDR0000393782

Identifier Type: -

Identifier Source: secondary_id

040280

Identifier Type: -

Identifier Source: org_study_id

NCT00092261

Identifier Type: -

Identifier Source: nct_alias