Paclitaxel and ABI-007 in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Unspecified Adult Solid Tumor, Protocol Specific
Intervention: paclitaxel (Drug); paclitaxel albumin-stabilized nanoparticle formulation (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: National Cancer Institute (NCI) Official(s) and/or principal investigator(s):
William D. Figg, PharmD, Study Chair, Affiliation: National Cancer Institute (NCI)
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.
Clinical Details
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
Study design: Treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland 20892-1182, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database Web site for additional information
Starting date: September 2004
Last updated: May 23, 2008
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