Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI NCI-04-C-0280 ABI-CA019, NCT00095914

Objectives

Primary

1. 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

1. Correlate pharmacokinetic data of this regimen with decrease in the neutrophil count at nadir in these patients.
2. Determine the intra- and interindividual pharmacokinetic variability of ABI-007 in these patients.
3. Determine protein binding of paclitaxel via measurement of α-1-acid glycoprotein and serum albumin levels in patients treated with this regimen.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

A total of 20 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

William Figg, PharmD, Protocol chair		Ph: 301-402-3622 Email: wdfigg@helix.nih.gov

Related Information

Web site for additional information

Registry Information
Official Title		Randomized, Crossover, Pharmacokinetic Study Of Paclitaxel (Taxol®) And ABI-007 (A Cremophor® EL-Free, Protein Stabilized, Nanoparticle Paclitaxel) In Patients With Advanced Solid Tumors
Trial Start Date		2004-09-28
Registered in ClinicalTrials.gov		NCT00095914
Date Submitted to PDQ		2004-09-28
Information Last Verified		2006-07-06

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