A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer

NCT00723957 | Completed Phase 2 Results

• 1 other identifier: CA163-163
• Study Type: interventional
• Target: 260
• Locations: 10 countries
• Sites: 33

Brief Summary

The purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.

Conditions

Advanced/Metastatic Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors

  Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on-study tumor assessment, progression-free survival was censored at the date of randomization. A tumor was considered to be beta III (βIII)-tubulin positive if 50% or more of the tumor cells had a βIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control.

  Randomization to disease progression or death (maximum reached: 14.39 months )

Secondary Outcomes (8)

• Progression-free Survival in the Subgroup of Participants With βIII-tubulin Negative Tumors

  Randomization to disease progression or death (maximum reached: 12.29 months)

• Progression-free Survival in the Overall Population

  Randomization to disease progression or death, assessed to 12.29 months

• Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR)

  At randomization and then every 6 weeks to date of CR, PR, or progression for 6 21-day cycles

• Time to Response

  Randomization to date of first response (PR or CR)

• Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy

  Days 1 through 21, continuously

Study Arms (2)

Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)

EXPERIMENTAL

Drug: Ixabepilone, 32 mg/m^2; Drug: Carboplatin (area under the concentration curve [AUC] 6)

Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)

ACTIVE COMPARATOR

Drug: Paclitaxel, 200 mg/m^2; Drug: Carboplatin (area under the concentration curve [AUC] 6)

Interventions

Ixabepilone, 32 mg/m^2 DRUG

Intravenous (IV) solutions, ixabepilone, 32 mg/m\^2

Also known as: IXEMPRA, BMS-247550

Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)

Paclitaxel, 200 mg/m^2 DRUG

IV solutions, paclitaxel, 200 mg/m\^2

Also known as: TAXOL, BMS-181339, PARAPLATIN, BMY-26575

Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)

Carboplatin (area under the concentration curve [AUC] 6) DRUG

Carboplatin (AUC 6) day 1, every 21 days, 6 cycles

Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6); Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed non-small cell lung cancer (NSCLC)(squamous cell, adenocarcinoma, large cell, or bronchoalveolar carcinoma)
• Stage IIIB NSCLC with pleural effusion, Stage IV NSCLC, or recurrent disease following surgery with or without radiation therapy
• Available paraffin-embedded tissue to measure the expression levels of βIII tubulin
• Disease measurable by Response Evaluation Criteria in Solid Tumors, with at least 1 target lesion situated outside any previous radiotherapy field
• Karnofsky performance status of 70-100
• Life expectancy of at least 3 months
• Men and women, ages 18 years and older

You may not qualify if:

• Uncontrolled brain metastases
• Peripheral neuropathy greater than Grade 1
• Fewer than 4 weeks from prior radiation therapy or locoregional surgeries to randomization date (less than 1 week from focal/palliative radiotherapy or minor surgery)
• Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
• Known HIV-positive status
• Absolute neutrophil count lower than 1500 cells mm\^3
• Total bilirubin level higher than upper limit of normal (ULN) as defined by the institution (with the exception of elevation due to Gilbert's syndrome)
• Aspartate transaminase or alanine transaminase level higher than 2.5\*ULN
• Serum creatine level of 1.5 mg/dL or higher
• Renal function with a creatinine clearance of less than 50 mL/min (as calculated with the Cockcroft and Gault equation)
• Any prior antineoplastic systemic regimens.

Sponsors & Collaborators

• R-Pharm: lead

Study Sites (33)

Scripps Cancer Center

La Jolla, California, 90237, United States

Location

Uof Md,Greenebaum Cancer Ctr.

Baltimore, Maryland, 21201, United States

Location

Local Institution

Capital Federal, Buenos Aires, 1425, Argentina

Location

Local Institution

Capital Federal, Buenos Aires, 1437, Argentina

Location

Local Institution

Buenos Aires, C1426ANZ, Argentina

Location

Local Institution

Bankstown, New South Wales, 2200, Australia

Location

Local Institution

Frankston, Victoria, 3199, Australia

Location

Local Institution

Nedlands, Western Australia, 6009, Australia

Location

Local Institution

Poitiers, 86021, France

Location

Local Institution

Strasbourg, 67085, France

Location

Local Institution

Strasbourg, 67090, France

Location

Local Institution

Bad Berka, 99437, Germany

Location

Local Institution

Großhansdorf, 22927, Germany

Location

Local Institution

Ulm, 89081, Germany

Location

Local Institution

Genova, 16132, Italy

Location

Local Institution

Milan, 20133, Italy

Location

Local Institution

Sondrio, 23100, Italy

Location

Local Institution

Terni, 05100, Italy

Location

Local Institution

Chelyabinsk, 454087, Russia

Location

Local Institution

Kazan', 420029, Russia

Location

Local Institution

Moscow, 115 478, Russia

Location

Local Institution

Moscow, 129128, Russia

Location

Local Institution

Ryazan, 390011, Russia

Location

Local Institution

Saint Petersburg, 194291, Russia

Location

Local Institution

Saint Petersburg, 198255, Russia

Location

Local Institution

Goyang-si, Gyeonggi-do, 411-769, South Korea

Location

Local Institution

Seoul, 120-752, South Korea

Location

Local Institution

Seoul, 135-710, South Korea

Location

Local Institution

Seoul, 138-736, South Korea

Location

Local Institution

Baracaldo (Vizcaya), 48903, Spain

Location

Local Institution

Taichung, 407.5, Taiwan

Location

Local Institution

Taipei, 112, Taiwan

Location

Local Institution

Taoyuan Hsien, 333, Taiwan

Location

Related Publications (1)

• Edelman MJ, Schneider CP, Tsai CM, Kim HT, Quoix E, Luft AV, Kaleta R, Mukhopadhyay P, Trifan OC, Whitaker L, Reck M. Randomized phase II study of ixabepilone or paclitaxel plus carboplatin in patients with non-small-cell lung cancer prospectively stratified by beta-3 tubulin status. J Clin Oncol. 2013 Jun 1;31(16):1990-6. doi: 10.1200/JCO.2012.45.3282. Epub 2013 Apr 15.

  PMID: 23589560 DERIVED

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ixabepilone; Paclitaxel; BMS 181339; Carboplatin; Area Under Curve

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Pharmacokinetics; Metabolism; Pharmacological and Toxicological Phenomena; Physiological Phenomena; Public Health; Environment and Public Health

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: August 1, 2011
• Last Updated: October 28, 2020
• Results First Posted: October 17, 2011

Record last verified: 2020-10

Locations

RU (7); DE (3); KR (4); AU (3); US (2); TW (3); ES (1); IT (4); FR (3); AR (3)