Paclitaxel and ABI-007 in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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
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Correlate pharmacokinetic data of this regimen with decrease in the neutrophil count at nadir in these patients.
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Determine the intra- and interindividual pharmacokinetic variability of ABI-007 in these patients.
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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.
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Courses 1 and 2: Patients are randomized to 1 of 2 treatment arms.
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Arm I: Patients receive paclitaxel IV over 3 hours on day 1 and ABI-007 IV over 30 minutes on day 22.
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Arm II: Patients receive ABI-007 IV over 30 minutes on day 1 and paclitaxel IV over 3 hours on day 22.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed malignant solid tumor
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Considered incurable
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Locally advanced or metastatic disease
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Likely to be responsive to taxane-based therapy
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Patients who are refractory to prior paclitaxel are ineligible
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No symptomatic or untreated brain metastasis or carcinomatous meningitis
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No patients who are unable to remain free of corticosteroid therapy for > 4 weeks due to CNS disease
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No previously untreated locally advanced breast cancer
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No hematologic malignancy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 3 months
Hematopoietic
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Granulocyte count ≥ 1,500/mm^3
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Platelet count ≥ 100,000/mm^3
Hepatic
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Bilirubin normal
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ALT and AST ≤ 1.5 times upper limit of normal
Renal
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Creatinine normal OR
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Creatinine clearance ≥ 60 mL/min
Cardiovascular
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LVEF ≥ 40%
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No clinical signs or symptoms of heart failure
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No symptomatic congestive heart failure
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No unstable angina pectoris
Other
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception during and for 2 months after study participation
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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])
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No history of seizure disorder requiring anticonvulsant therapy
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No active serious infection
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No psychiatric illness or social situation that would preclude study compliance
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No other uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
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No concurrent immunotherapy
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No concurrent filgrastim (G-CSF) during courses 1 and 2
Chemotherapy
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See Disease Characteristics
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At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
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No other concurrent chemotherapy
Endocrine therapy
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See Disease Characteristics
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At least 2 weeks since prior hormonal therapy
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Concurrent luteinizing hormone-releasing hormone agonists for prostate cancer allowed
Radiotherapy
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At least 3 weeks since prior radiotherapy
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No concurrent radiotherapy
Surgery
- Not specified
Other
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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
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No concurrent substances known or likely to interfere with the pharmacokinetics of paclitaxel (e.g., verapamil or cyclosporine)
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No other concurrent investigational agents
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No other concurrent anticancer therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland | United States | 20892-1182 |
Sponsors and Collaborators
- National Institutes of Health Clinical Center (CC)
- National Cancer Institute (NCI)
Investigators
- Study Chair: William D. Figg, PharmD, National Cancer Institute (NCI)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 040280
- 04-C-0280
- ABI-CA019
- CDR0000393782
- NCT00092261