Status:
COMPLETED
ABI-007 in Treating Patients With Chemotherapy-Naïve Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I/II trial is studying the side effec...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose and dose-limiting toxicity of paclitaxel (albumin-stabilized Nanoparticle formulation) (ABI-007) in patients with chemotherapy-naïve stage ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed stage IV non-small cell lung cancer
- Evidence of inoperable local recurrence or metastasis
- Bone metastases or other nonmeasurable disease may not be only evidence of metastasis
- Measurable disease documented radiographically
- No evidence of active brain metastases or leptomeningeal involvement
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-1 OR
- Karnofsky 80-100%
- Life expectancy
- More than 12 weeks
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL
- Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin normal
- Alkaline phosphatase ≤ 2.5 times ULN (unless due to bone metastases and there is no radiologic evidence of hepatic metastases)
- Renal
- Creatinine ≤ 1.5 mg/dL
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception for 1 month before and during study participation
- No prior allergy or hypersensitivity to study drug
- No other concurrent active malignancy
- No pre-existing peripheral neuropathy grade 1 or greater
- No other concurrent clinically significant illness
- No concurrent serious medical risk factor involving any of the major organ systems that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No prior chemotherapy for metastatic disease
- More than 4 weeks since prior cytotoxic chemotherapy
- No concurrent doxorubicin
- No other concurrent taxanes
- No concurrent anthracyclines
- Endocrine therapy
- Not specified
- Radiotherapy
- At least 3 weeks since prior radiotherapy to a major bone marrow-containing area
- More than 4 weeks since prior radiotherapy except to a non-target lesion
- Prior radiotherapy to a target lesion allowed provided there has been clear progression of the lesion since completion of radiotherapy
- Surgery
- Not specified
- Other
- Prior epidermal growth factor-targeted therapy allowed
- More than 4 weeks since prior investigational drugs
- No concurrent enrollment in another clinical trial in which investigational drugs are administered or investigational procedures are performed
- No concurrent treatment with any of the following:
- Ritonavir
- Saquinavir
- Indinavir
- Nelfinavir
- No concurrent anticonvulsants
- No other concurrent anticancer drugs
- No other concurrent investigational drugs
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00077246
Start Date
September 1 2003
Last Update
November 6 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021