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Clinical Trials (PDQ®)

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

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IBiomarker/Laboratory analysis, TreatmentCompleted18 and overNCI, NIH WGMCC040280
04-C-0280, ABI-CA019, CDR0000393782, NCI-04-C-0280, NCT00095914

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

National Cancer Institute

William D. FiggStudy Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00095914
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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