ABI-007 in Treating Patients With Chemotherapy-Naïve Stage IV Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00077246
First received: February 10, 2004
Last updated: January 7, 2012
Last verified: December 2009
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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: This phase I/II trial is studying the side effects and best dose of ABI-007 and to see how well it works in treating patients with stage IV non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: paclitaxel albumin-stabilized nanoparticle formulation |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Phase I/II Trial Of ABI-007 (A CREMOPHOR® El-Free, Protein Stabilized, Nanoparticle Paclitaxel) Administered Weekly In Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007 [ Designated as safety issue: Yes ]
- Objective target lesion response (complete or partial) as measured by RECIST criteria [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of treatment-emergent adverse events and serious adverse events [ Designated as safety issue: Yes ]
- Nadir of myelosuppression [ Designated as safety issue: No ]
- Changes in hematologic and clinical chemistry values [ Designated as safety issue: No ]
- Changes in physical examination [ Designated as safety issue: No ]
- Incidence of dose modifications, dose interruptions, and/or premature discontinuation of study treatment [ Designated as safety issue: No ]
- Percentage of patients with stable disease for ≥ 16 weeks [ Designated as safety issue: No ]
- Percentage of patients with complete or partial target response (total response) [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 64 |
| Study Start Date: | September 2003 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
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 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.
- Phase I: Patients receive paclitaxel (albumin-stabilized Nanoparticle formulation) (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 64 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077246
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Study Chair: | Naiyer Rizvi, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00077246 History of Changes |
| Other Study ID Numbers: | CDR0000350076, MSKCC-03111, ABI-CA015 |
| Study First Received: | February 10, 2004 |
| Last Updated: | January 7, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV non-small cell lung cancer recurrent non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013