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Sponsored by: |
Cell Therapeutics |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00551733 |
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.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: carboplatin Drug: paclitaxel Drug: paclitaxel poliglumex |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women With Estradiol >30 pg/mL |
Estimated Enrollment: | 450 |
Study Start Date: | August 2007 |
Arms | Assigned Interventions |
---|---|
Arm I: Experimental
Patients receive paclitaxel poliglumex IV over 10 minutes followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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Drug: carboplatin
Given IV
Drug: paclitaxel poliglumex
Given IV
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Arm II: Active Comparator
Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
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OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
Must meet one of the following criteria:
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
PATIENT CHARACTERISTICS:
Meets all of the following criteria:
No unstable medical conditions including unstable angina or myocardial infarction within the past 6 months
PRIOR CONCURRENT THERAPY:
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)
Study Chair: | Fred B. Oldham, MD | Cell Therapeutics |
Study ID Numbers: | CDR0000573340, CTI-PGT-07-0040(0), EUDRACT-2007-004167-22 |
Study First Received: | October 30, 2007 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00551733 |
Health Authority: | Unspecified |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Estradiol valerate Carboplatin Estradiol 17 beta-cypionate Estradiol Recurrence Carcinoma |
Respiratory Tract Diseases Lung Neoplasms Paclitaxel Lung Diseases Estradiol 3-benzoate Polyestradiol phosphate Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |