Lung Cancer Clinical Trial

Carboplatin With Either Paclitaxel Poliglumex or Paclitaxel in Treating Women With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, and paclitaxel poliglumex, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving carboplatin together with paclitaxel poliglumex is more effective than giving carboplatin together with paclitaxel in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel poliglumex to see how well they work compared with carboplatin and paclitaxel in treating women with stage III, stage IV, or recurrent non-small cell lung cancer.

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Full Description

OBJECTIVES:

Primary

Compare the overall survival of patients with chemotherapy-naïve stage IIIB or IV or recurrent non-small cell lung cancer treated with paclitaxel poliglumex and carboplatin vs paclitaxel and carboplatin.

Secondary

Compare the progression-free survival of women treated with these regimens.
Compare the disease control in women treated with these regimens.
Compare the clinical benefit in women treated with these regimens.
Compare the response rate in women treated with these regimens.
Compare the quality of life of women treated with these regimens.
Compare the safety and tolerability in women treated with these regimens.

OUTLINE: This is a multicenter study.

Patients are stratified according to age (≥ 60 vs < 60 years old), geographical location (United States of America, Canada, or Australia vs the rest of the world), extent of disease (independent of brain metastases, i.e., brain metastases are not considered in determining extent of disease) (intrathoracic disease only vs extrathoracic disease), and ECOG performance status (0 or 1 vs 2). Patients will be randomized to 1 of 2 treatment arms.

Arm I: Patients receive paclitaxel poliglumex IV over 10 minutes followed by carboplatin IV over 30 minutes on day 1.
Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1.

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each course, and at the completion of study treatment by the Pain Assessment Patient Questionnaire, the Pulmonary Symptom Index, and the Functional Assessment of Cancer Therapy- Lung Cancer Subscale (FACT-LCS) (only in countries in which a validated translation is currently available).

After completion of study therapy, patients are followed at least monthly.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)

Cytologic specimens obtained by brushings, washings, or needle aspiration of a defined lesion or from a pleural effusion are acceptable; sputum cytology alone is not acceptable for determining cell type

Must meet one of the following criteria:

Recurrent disease following completion of radiation or surgery
Stage IIIB disease and not a candidate for combined modality therapy (primary radiation therapy or surgery)
Stage IV disease
Patients may have either measurable or nonmeasurable disease according to RECIST criteria

Baseline estradiol > 30 pg/mL

Patients on hormone replacement therapy are eligible provided baseline estradiol > 30 pg/mL

Patients with known brain metastases must have received standard antitumor treatment (e.g. whole brain radiation, stereotactic radioablation, or surgery) for their CNS metastases as defined by the site's institutional standards

Neurologic function must have been stable for 2 weeks before randomization and patients must either be off steroid therapy for their brain metastases or on a tapering regimen
Patients must have recovered from therapy for their brain metastases with no evidence of significant unstable neurological symptoms within the 4 weeks before study randomization
No evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology

PATIENT CHARACTERISTICS:

Female
ECOG performance score 0-2
Life expectancy ≥ 12 weeks
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 10 g/dL (may be achieved with transfusion)
Creatinine ≤ 1.5 times upper limit of normal (ULN)
Total bilirubin ≤ 1.5 times ULN (CTC grade 1) (patients with Gilbert syndrome or other hereditary bilirubin defects may be included regardless of bilirubin levels)
SGOT and SGPT ≤ 2.5 times ULN (CTC grade 0 or 1) (5 times ULN [CTC grade 0 to 2] if due to liver metastases)
Alkaline phosphatase ≤ 2.5 times ULN except for elevated alkaline phosphatase with laboratory documentation that demonstrates bone origin
No pregnant women or nursing mothers
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after study participation
No known hypersensitivity to study drugs or excipients

Meets all of the following criteria:

No weight loss > 10% in previous 6 months
Lactate dehydrogenase (LDH) ≤ 600 IU/L (central laboratory) regardless of weight loss
LDH ≤ 400 IU/L (central laboratory) and no weight loss ≥ 5% in previous 6 months
BMI ≤ 35
No concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer
No neuropathy grade 2 or greater
No clinically significant active infection for which active therapy is underway

No unstable medical conditions including unstable angina or myocardial infarction within the past 6 months

Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status is stable
No circumstance that would preclude completion of the study or the required follow-up

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Recovered from major surgery
At least 7 days since prior local palliative radiotherapy
At least 30 days since prior radiation therapy with curative intent
At least 4 weeks since prior investigational therapy, unless local requirements are more stringent
No prior systemic chemotherapy for the treatment of lung cancer, including systemic radiosensitizers used to treat brain metastases or any biologic agents
No concurrent non-protocol-specified systemic antitumor therapy
No concurrent amifostine, investigational agents, other cytotoxic agents for this disease

No concurrent radiotherapy (with the exception of radiotherapy for brain or bone metastases for palliative purposes or radiotherapy for a condition other than NSCLC that was ongoing at the time of randomization)

Patients receiving palliative radiotherapy (treatment for symptomatic metastatic disease) may be treated while on study

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

450

Study ID:

NCT00551733

Recruitment Status:

Terminated

Sponsor:

CTI BioPharma

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There are 41 Locations for this study

See Locations Near You

Scottsdale Medical Specialists
Scottsdale Arizona, 85258, United States
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank California, 91505, United States
Southwest Cancer Care - Escondido
Escondido California, 92025, United States
Clinical Trials and Research Associates, Incorporated
Montebello California, 90640, United States
Stanford Cancer Center
Stanford California, 94305, United States
Broward Oncology Associates
Fort Lauderdale Florida, 33308, United States
Horizon Institute for Clinical Research
Hollywood Florida, 33021, United States
Rush Cancer Institute at Rush University Medical Center
Chicago Illinois, 60612, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
Hematology Oncology Consultants - Naperville
Naperville Illinois, 60565, United States
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
Olympia Fields Illinois, 60461, United States
Cancer Center of Indiana
New Albany Indiana, 47150, United States
Providence Medical Group
Terre Haute Indiana, 47802, United States
Family Medicine of Vincennes Clinical Trial Center
Vincennes Indiana, 47591, United States
West Michigan Regional Cancer and Blood Center
Free Soil Michigan, 49411, United States
Newland Medical Associates PC - Southfield
Southfield Michigan, 48275, United States
Hattiesburg Clinic, PA at Forrest General
Hattiesburg Mississippi, 39401, United States
Columbia Comprehensive Cancer Care Clinic
Columbia Missouri, 65201, United States
Kansas City Cancer Centers - South
Kansas City Missouri, 64131, United States
Saint Louis University Cancer Center
Saint Louis Missouri, 63110, United States
Las Vegas Cancer Center
Las Vegas Nevada, 89102, United States
Veterans Affairs Medical Center - Reno
Reno Nevada, 89520, United States
Lincoln Medical and Mental Health Center
Bronx New York, 10451, United States
Richmond University Medical Center
Staten Island New York, 10310, United States
New York Medical College
Valhalla New York, 10595, United States
Mid Dakota Clinic, PC
Bismarck North Dakota, 58501, United States
Blood and Cancer Center, Incorporated
Canfield Ohio, 44406, United States
Aultman Cancer Center at Aultman Hospital
Canton Ohio, 44710, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio, 45219, United States
Oklahoma University Cancer Institute
Oklahoma City Oklahoma, 73104, United States
Vita Hematology Oncology at St. Luke's Hospital
Bethlehem Pennsylvania, 18015, United States
Cancer Centers of the Carolinas - Eastside
Greenville South Carolina, 29615, United States
Family Cancer Center, PLLC - Collierville
Collierville Tennessee, 38077, United States
Mid-South Cancer Center
Germantown Tennessee, 38138, United States
Southwest Regional Cancer Center - Central
Austin Texas, 78705, United States
Lone Star Oncology - Austin
Austin Texas, 78759, United States
Mary Crowley Medical Research Center at Sammons Cancer Center
Dallas Texas, 75246, United States
Utah Hematology Oncology, PC
Ogden Utah, 84403, United States
Cancer Outreach Associates - Abingdon
Abingdon Virginia, 24211, United States
Virginia Mason Medical Center
Seattle Washington, 98101, United States
Cell Therapeutics, Incorporated
Seattle Washington, 98119, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

450

Study ID:

NCT00551733

Recruitment Status:

Terminated

Sponsor:


CTI BioPharma

How clear is this clinincal trial information?

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