|Phase I||Biomarker/Laboratory analysis, Treatment||Completed||18 and over||NCI, NIH WGMCC||040280|
04-C-0280, ABI-CA019, CDR0000393782, NCI-04-C-0280, NCT00095914
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.
Further Study Information
- 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.
- 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.
- 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
- 18 and over
- ECOG 0-2
- At least 3 months
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin normal
- ALT and AST ≤ 1.5 times upper limit of normal
- Creatinine normal OR
- Creatinine clearance ≥ 60 mL/min
- LVEF ≥ 40%
- No clinical signs or symptoms of heart failure
- No symptomatic congestive heart failure
- No unstable angina pectoris
- 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:
- No concurrent immunotherapy
- No concurrent filgrastim (G-CSF) during courses 1 and 2
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No other concurrent chemotherapy
- See Disease Characteristics
- At least 2 weeks since prior hormonal therapy
- Concurrent luteinizing hormone-releasing hormone agonists for prostate cancer allowed
- At least 3 weeks since prior radiotherapy
- No concurrent radiotherapy
- Not specified
- 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 Lead Organizations/Sponsors
NIH - Warren Grant Magnuson Clinical CenterNational Cancer Institute
|William D. Figg||Study Chair|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00095914
Information obtained from ClinicalTrials.gov on November 20, 2012
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