Carboplatin, Paclitaxel and TLK286 (Telcyta) as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Registration Number
- NCT00088556
- Lead Sponsor
- Telik
- Brief Summary
The purpose of this trial is to study the efficacy and safety of the triplet combination of TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 18 years of age or older
- Histologically confirmed non-small cell lung cancer (NSCLC)
- Stage IV or IIIB (disease that is not eligible for combined modality chemotherapy and radiation)
- Measurable disease by RECIST
- ECOG status of 0-1
- Adequate liver and renal function
- Adequate bone marrow reserves
- Prior chemotherapy, immunotherapy or biologic therapy for metastatic NSCLC
- Up to one prior adjuvant or neoadjuvant chemotherapy is allowed
- History of bone marrow transplantation or stem cell support
- Pregnant or lactating women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Triplet Combination of TLK286 Carboplatin & Paclitaxel TLK286 Experimental Triplet Combination of TLK286 Carboplatin & Paclitaxel paclitaxel Experimental Triplet Combination of TLK286 Carboplatin & Paclitaxel carboplatin Experimental
- Primary Outcome Measures
Name Time Method Study Objectives Every 6 Weeks 1. To determine the MTD of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin
2. To determine the safety of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin
3. To determine the objective response rate (ORR) of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
East Bay Medical Oncology/Hematology Associates
🇺🇸Concord, California, United States
Bay Area Cancer Research Group
🇺🇸Concord, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Kaiser Permanente Medical Center
🇺🇸Walnut Creek, California, United States
Kansas City Cancer Center - Central Research Dept. Data Office & Drug Discovery Location
🇺🇸Lenexa, Kansas, United States
Dakota Cancer Institute
🇺🇸Fargo, North Dakota, United States
Odyssey Research
🇺🇸Fargo, North Dakota, United States
Citrus Hematology and Oncology
🇺🇸Crystal River, Florida, United States
Department of Veterns Affairs - Overton Brooks VA Medical Center
🇺🇸Shreveport, Louisiana, United States
Horizons West Medical Group
🇺🇸Scottsbluff, Nebraska, United States
University of Maryland, Baltimore University of Maryland Medical System-Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
Center for Cancer and Blood Disorders, P. C.
🇺🇸Bethesda, Maryland, United States
LSU Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Citrus Hematology and Oncology Center
🇺🇸Inverness, Florida, United States
Florida Wellcare Alliance, LC
🇺🇸Inverness, Florida, United States
Kansas City Cancer Center
🇺🇸Lee's Summit, Missouri, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Southwest Cancer Care
🇺🇸Poway, California, United States
Diablo Valley Oncology & Hematology Medical Group
🇺🇸Walnut Creek, California, United States
St. John's Mercy Hospital
🇺🇸Washington, Missouri, United States
St. John's Mercy Medical Center
🇺🇸St. Louis, Missouri, United States
Danville Hematology & Oncology, Inc.
🇺🇸Danville, Virginia, United States
Texas Cancer Associates
🇺🇸Plano, Texas, United States
Tennessee Oncology, PLLC
🇺🇸Smyrna, Tennessee, United States
Clinical Research Service
🇺🇸Scottsbluff, Nebraska, United States