ABI-007 in Treating Patients With Chemotherapy-Naïve Stage IV Non-Small Cell Lung Cancer
This study is currently recruiting patients.
Sponsored by: |
Memorial Sloan-Kettering Cancer Center
|
Information provided by: |
National Cancer Institute (NCI) |
Purpose
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: Phase I/II trial to study the effectiveness of ABI-007 in treating patients who have stage IV non-small cell lung
cancer.
Condition
|
Treatment or Intervention |
Phase |
stage IV non-small cell lung cancer recurrent non-small cell lung cancer
|
Drug: ABI-007 Procedure: chemotherapy
|
Phase I Phase II
|
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Lung Cancer; Respiratory Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Study of ABI-007 in Patients With Chemotherapy-Naïve Stage IV Non-Small Cell Lung Cancer
Further Study Details:
OBJECTIVES: Primary
- Determine the maximum tolerated dose and dose-limiting toxicity of ABI-007 in patients with chemotherapy-naïve stage IV non-small
cell lung cancer.
- Determine the antitumor activity of this drug in these patients.
- Determine the safety and tolerability of this drug in these patients.
Secondary
- Determine the time to disease progression in patients treated with this drug.
- Determine duration of response in patients treated with this drug.
- Determine survival of patients treated with this drug.
OUTLINE: This is an open-label, dose-escalation study.
- Patients receive ABI-007 IV on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients receive escalating doses of ABI-007 until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive ABI-007 as above at the MTD (determined in phase I). Patients are followed monthly for 6 months
and then every 3 months for 1.5 years.
PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for phase I and 40 for phase II) will be accrued for this study.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
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
Performance status
- ECOG 0-1 OR
- Karnofsky 80-100%
Life expectancy
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
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
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
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
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
Location
and Contact
Information
New York Memorial Sloan-Kettering Cancer Center, New York,
New York,
10021,
United States; Recruiting
Naiyer Rizvi, MD
212-639-3204
Study chairs or principal investigators
Naiyer Rizvi, MD, Study Chair, Memorial Sloan-Kettering Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000350076; MSKCC-03111; ABI-CA015
Record last reviewed:
January 2004
Record first received:
February 10, 2004
ClinicalTrials.gov Identifier:
NCT00077246Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-22