Status:
COMPLETED
Paclitaxel and ABI-007 in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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 tum...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00095914
Start Date
September 1 2004
End Date
March 1 2009
Last Update
March 15 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182