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ABI-007 in Treating Patients With Chemotherapy-Naïve Stage IV Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
paclitaxel albumin-stabilized nanoparticle formulation
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007
Objective target lesion response (complete or partial) as measured by RECIST criteria

Secondary Outcome Measures

Incidence of treatment-emergent adverse events and serious adverse events
Nadir of myelosuppression
Changes in hematologic and clinical chemistry values
Changes in physical examination
Incidence of dose modifications, dose interruptions, and/or premature discontinuation of study treatment
Percentage of patients with stable disease for ≥ 16 weeks
Percentage of patients with complete or partial target response (total response)
Time to disease progression
Duration of response
Survival

Full Information

First Posted
February 10, 2004
Last Updated
November 5, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00077246
Brief Title
ABI-007 in Treating Patients With Chemotherapy-Naïve Stage IV Non-Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paclitaxel albumin-stabilized nanoparticle formulation
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007
Title
Objective target lesion response (complete or partial) as measured by RECIST criteria
Secondary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events and serious adverse events
Title
Nadir of myelosuppression
Title
Changes in hematologic and clinical chemistry values
Title
Changes in physical examination
Title
Incidence of dose modifications, dose interruptions, and/or premature discontinuation of study treatment
Title
Percentage of patients with stable disease for ≥ 16 weeks
Title
Percentage of patients with complete or partial target response (total response)
Title
Time to disease progression
Title
Duration of response
Title
Survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naiyer Rizvi, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21461889
Citation
Paik PK, James LP, Riely GJ, Azzoli CG, Miller VA, Ng KK, Sima CS, Heelan RT, Kris MG, Moore E, Rizvi NA. A phase 2 study of weekly albumin-bound paclitaxel (Abraxane(R)) given as a two-hour infusion. Cancer Chemother Pharmacol. 2011 Nov;68(5):1331-7. doi: 10.1007/s00280-011-1621-0. Epub 2011 Apr 3.
Results Reference
result
PubMed Identifier
18235124
Citation
Rizvi NA, Riely GJ, Azzoli CG, Miller VA, Ng KK, Fiore J, Chia G, Brower M, Heelan R, Hawkins MJ, Kris MG. Phase I/II trial of weekly intravenous 130-nm albumin-bound paclitaxel as initial chemotherapy in patients with stage IV non-small-cell lung cancer. J Clin Oncol. 2008 Feb 1;26(4):639-43. doi: 10.1200/JCO.2007.10.8605.
Results Reference
result

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ABI-007 in Treating Patients With Chemotherapy-Naïve Stage IV Non-Small Cell Lung Cancer

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