NCT00054210

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of chemotherapy is more effective in treating stage IIIB, stage IV, or recurrent non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel plus carboplatin to that of paclitaxel plus carboplatin in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_3 lung-cancer

Geographic Reach
2 countries

35 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2003

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

1.8 years

First QC Date

February 5, 2003

Last Update Submit

October 2, 2020

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Interventions

carboplatinDRUG
paclitaxelDRUG
paclitaxel poliglumexDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following criteria: * Locally advanced or recurrent disease previously treated with radiotherapy and/or surgery * Stage IIIB and not a candidate for combined modality therapy * Stage IV * No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology * Cytological diagnosis must be based on the following: * No cellular diagnosis by sputum cytology alone * Cytologic specimens obtained from brushings, washings, or needle aspiration of a defined lesion or pleural effusion are acceptable * Measurable or nonmeasurable disease * Brain metastases allowed provided patient received prior standard antitumor therapy for CNS metastases (e.g., whole brain radiotherapy, stereotactic radioablation, or surgery) and the following conditions are met: * Neurologic function stable for at least 2 weeks before study entry * Off steroid therapy or on a tapering regimen * Recovered from prior therapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than upper limit of normal (ULN) * SGOT/SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases present) * Alkaline phosphatase no greater than 2.5 times ULN (except for laboratory documentation that demonstrates bone origin) Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * No unstable angina * No myocardial infarction within the past 6 months * Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided cardiac status has been stable for at least 6 months prior to study entry Neurologic * See Disease Characteristics * No neuropathy greater than grade 1 * No evidence of unstable neurological symptoms within the past 4 weeks (2 weeks for neurological symptoms due to brain metastases) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No intolerance to excipients of polyglutamate paclitaxel (e.g., poly-L-glutamic acid, poloxamer 188, dibasic sodium phosphate, or monobasic sodium hydroxide) * No clinically significant active infection * No other concurrent primary malignancy except carcinoma in situ or nonmelanoma skin cancer * No other unstable medical conditions * No circumstance that would preclude study completion or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * No prior systemic biologic agent for lung cancer Chemotherapy * See Disease Characteristics * No prior systemic therapy for lung cancer including radiosensitizing agents Endocrine therapy * See Disease Characteristics Radiotherapy * See Disease Characteristics * No concurrent radiotherapy Surgery * See Disease Characteristics * Recovered from prior major surgery Other * More than 12 weeks since prior participation in any research study or treatment with investigational drugs * Recovered from prior investigational therapy or stable for 4 weeks before study treatment * No other concurrent investigational drugs * No other concurrent systemic antitumor therapy * No concurrent amifostine * Concurrent bisphosphonates allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (35)

Hematology and Oncology Associates of Alabama

Birmingham, Alabama, 35243, United States

Location

Clinical Research Consultants, Inc

Hoover, Alabama, 35216, United States

Location

Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

Synergy Hematology/Oncology Medical Associates

Encino, California, 91316, United States

Location

Holy Cross Providence Cancer Center

Mission Hills, California, 91345, United States

Location

Clinical Trials and Research Associates, Incorporated

Montebello, California, 90640, United States

Location

California Hematology/Oncology Medical Group

Torrance, California, 90505, United States

Location

Hematology Oncology, P.C.

Stamford, Connecticut, 06902, United States

Location

New Hope Cancer Centers

Hudson, Florida, 34667, United States

Location

Omni Healthcare, PA

Melbourne, Florida, 32901, United States

Location

MetCare Oncology

Ormond Beach, Florida, 32174, United States

Location

Hematology Oncology Associates of theTreasure Coast - Port St. Lucie

Port Saint Lucie, Florida, 34952, United States

Location

Northwest Georgia Oncology Centers, P.C.

Marietta, Georgia, 30060, United States

Location

Georgia Cancer Specialists - Tucker

Tucker, Georgia, 30084, United States

Location

Silver Cross Hospital

Joliet, Illinois, 60432, United States

Location

Gross Point Medical Center

Skokie, Illinois, 60077, United States

Location

Kentucky Cancer Clinic

Pikeville, Kentucky, 41501, United States

Location

Unknown Facility

Grand Rapids, Michigan, 49503, United States

Location

Hattiesburg Clinic, P.A.

Hattiesburg, Mississippi, 39401, United States

Location

Columbia Comprehensive Cancer Care Clinic

Columbia, Missouri, 65201, United States

Location

Bond Clinic

Rolla, Missouri, 65401, United States

Location

Las Vegas Cancer Center

Las Vegas, Nevada, 89102, United States

Location

Summit Medical Group, P.A.

Summit, New Jersey, 07901, United States

Location

Gabrail Cancer Center - Canton Office

Canton, Ohio, 44718, United States

Location

Oklahoma Oncology, Inc. - St. John Campus

Tulsa, Oklahoma, 74104, United States

Location

Charleston Cancer Center

Charleston, South Carolina, 29406, United States

Location

Santee Hematology Oncology

Sumter, South Carolina, 29150, United States

Location

Clarksville Regional Hematology/Oncology Group

Clarksville, Tennessee, 37043, United States

Location

Family Cancer Center

Collierville, Tennessee, 38017, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

Virginia Oncology Care P.C.

Richlands, Virginia, 24641, United States

Location

Highline Medical Oncology

Burien, Washington, 98166, United States

Location

Rainier Oncology

Puyallup, Washington, 98372, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

CarboplatinPaclitaxelpaclitaxel poliglumex

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Melinda Bomar

    PPD, Incorporated

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 5, 2003

First Posted

February 6, 2003

Study Start

January 1, 2003

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

October 5, 2020

Record last verified: 2020-10

Locations

CA(1)US(34)