A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00723957

Purpose

The purpose of this study is to determine if Ixabepilone combined with carboplatin is better than paclitaxel combined with carboplatin in a subgroup of patients with non-small cell lung cancer (NSCLC) whose tumors are positive for the βΙII isoform of tubulin

Condition	Intervention	Phase
Advanced/Metastatic Non-Small Cell Lung Cancer	Drug: Ixabepilone + Carboplatin Drug: Paclitaxel + Carboplatin	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Ixabepilone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To compare the progression-free survival (PFS) in the ixabepilone plus carboplatin arm to that in the paclitaxel plus carboplatin arm for the subgroup with βIII tubulin positive tumors (βIII tubulin positive subgroup). [ Time Frame: Assessed by tumor measurements (scans) every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression free survival rate [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Response rate and the disease control rate [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Time to response and duration of the best response [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Safety analysis [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	260
Study Start Date:	December 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Ixabepilone + Carboplatin Solutions, IV, Ixabepilone 32 mg/m2 + Carboplatin (AUC 6), day 1, every 21 days, 6 cycles
B: Active Comparator	Drug: Paclitaxel + Carboplatin Solutions, IV, Paclitaxel 200 mg/m2 + Carboplatin (AUC 6), day 1, every 21 days, 6 cycles

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed NSCLC (squamous cell, adenocarcinoma, large cell or bronchoalveolar carcinoma)
Stage IIIB with pleural effusion, or stage IV NSCLC, or recurrent disease following surgery and/or radiation therapy
Available paraffin embedded tissue to measure the expression levels of βIII tubulin
Measurable disease by RECIST guidelines, with at least one target lesion outside any previous radiotherapy field
Karnofsky performance status (KPS) of 70-100
Life expectancy of at least 3 months
Men and women, ages ≥18 years

Exclusion Criteria:

Uncontrolled brain metastases
Peripheral neuropathy > Grade 1
Less than 4 weeks from prior radiation therapy or loco-regional surgeries to randomization date (less than 1 week from focal/palliative radiotherapy or minor surgery)
Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix
Known HIV positive
Absolute neutrophil count (ANC) <1500 cells mm³
Total bilirubin greater than Upper Limit of Normal (ULN) as defined by the Institution (with the exception of elevation due to Gilbert's syndrome)
Aspartate transaminase (AST) or alanine transaminase (ALT) > 2.5 x ULN
Serum creatine ≥1.5 mg/dL
Renal function with a calculated creatinine clearance (CrCl) based on Cockcroft and Gault < 50 mL/min
Any prior antineoplastic systemic regimens. Subjects must not initiate any concurrent antineoplastic therapy (i.e. chemotherapy, hormonal therapy, immunotherapy, radiation therapy, herbal regimens or standard of investigational agents for treatment of NSCLC)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723957

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 46 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA163-163
Study First Received:	July 25, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00723957 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Epothilones
Carboplatin
Antimitotic Agents
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms

Paclitaxel
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Epothilones
Mitosis Modulators
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma

Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009