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| Sponsor: | Cell Therapeutics |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00054197 |
Purpose
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 whether polyglutamate paclitaxel is more effective than gemcitabine or vinorelbine in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of polyglutamate paclitaxel with that of gemcitabine or vinorelbine in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: gemcitabine hydrochloride Drug: paclitaxel poliglumex Drug: vinorelbine tartrate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CT-2103 vs Gemcitabine or Vinorelbine for the Treatment of PS = 2 Patients With Chemotherapy Naive Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Study |
| Study Start Date: | January 2003 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender, disease stage (IV vs other), geographic location (US vs Western Europe and Canada vs the rest of the world), and prior brain metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Treatment repeats in both arms for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 weeks and then every 8 weeks thereafter.
PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this study within 13 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:
Cytological diagnosis must be based on the following:
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:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Neurologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Alabama | |
| Cooper Green Hospital | |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| Medical Oncology/Hematology | |
| Gilroy, California, United States, 95020 | |
| United States, Florida | |
| Northwest Oncology and Hematology Associates | |
| Coral Springs, Florida, United States, 33065 | |
| United States, Illinois | |
| Midwest Cancer Research Group, Incorporated | |
| Skokie, Illinois, United States, 60077 | |
| United States, Nevada | |
| Medschool Associates North | |
| Reno, Nevada, United States, 89502 | |
| United States, New York | |
| New York Oncology Hematology, P.C. - Latham | |
| Latham, New York, United States, 12110-0610 | |
| United States, North Dakota | |
| Clinical Research Services | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, South Carolina | |
| Charleston Hematology-Oncology, P.A. | |
| Charleston, South Carolina, United States, 29403 | |
| United States, Washington | |
| Western Washington Medical Group | |
| Everett, Washington, United States, 98201 | |
| Western Washington Oncology, Incorporated | |
| Olympia, Washington, United States, 98502 | |
| Study Chair: | Meghann Smith | PPD, Incorporated |
More Information
| ClinicalTrials.gov Identifier: | NCT00054197 History of Changes |
| Other Study ID Numbers: | CDR0000269908, CTI-PGT304 |
| Study First Received: | February 5, 2003 |
| Last Updated: | February 23, 2011 |
| Health Authority: | United States: Federal Government |
|
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Vinorelbine Vinblastine Paclitaxel Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents |