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

N

National Institutes of Health Clinical Center (CC)

Status and phase

Completed
Phase 1

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Drug: paclitaxel
Drug: paclitaxel albumin-stabilized nanoparticle formulation

Study type

Interventional

Funder types

NIH

Identifiers

NCT00095914
ABI-CA019
CDR0000393782
04-C-0280
040280

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 contacts and locations

0

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Data sourced from clinicaltrials.gov

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