Phase 1-2a Dose-Ranging Study of the Triplet Combination of Carboplatin, Paclitaxel and TLK286 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
18 Years
N/A
Both
Carcinoma, Non-Small-Cell Lung
Trial Information
Phase 1-2a Dose-Ranging Study of the Triplet Combination of Carboplatin, Paclitaxel and TLK286 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Study Objectives
Outcome Description:
To determine the MTD of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin To determine the safety of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin To determine the objective response rate (ORR) of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin
Outcome Time Frame:
Every 6 Weeks
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
TLK286.2023
NCT ID:
NCT00088556
Start Date:
August 2004
Completion Date:
May 2009
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Non-small cell lung cancer
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Dakota Cancer Institute | Fargo, North Dakota 58103-4940 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| St. John's Mercy Medical Center | Saint Louis, Missouri 63141 |
| Southwest Cancer Care | Poway, California 92064 |
| Kaiser Permanente Medical Center | Vallejo, California 94589 |
| Texas Cancer Associates | Dallas, Texas 75231 |
| Bay Area Cancer Research Group | Concord, California 94520 |
| Danville Hematology & Oncology, Inc. | Danville, Virginia 24541 |
| Kansas City Cancer Center | Kansas City, Missouri 64111 |
| LSU Health Sciences Center | Shreveport, Louisiana 71130-3932 |
| Kansas City Cancer Center | Kansas City, Kansas 66112 |
| Horizons West Medical Group | Scottsbluff, Nebraska 69361 |
| Odyssey Research | Bismarck, North Dakota 58501 |
| East Bay Medical Oncology/Hematology Associates | Concord, California 94520 |
| Diablo Valley Oncology & Hematology Medical Group | Walnut Creek, California 94520 |
| Citrus Hematology and Oncology | Crystal River, Florida 34429 |
| Citrus Hematology and Oncology Center | Inverness, Florida 34452 |
| Florida Wellcare Alliance, LC | Inverness, Florida 34452 |
| Kansas City Cancer Center - Central Research Dept. Data Office & Drug Discovery Location | Lenexa, Kansas 66214 |
| Department of Veterns Affairs - Overton Brooks VA Medical Center | Shreveport, Louisiana 71101 |
| University of Maryland, Baltimore University of Maryland Medical System-Greenebaum Cancer Center | Baltimore, Maryland 21201 |
| Center for Cancer and Blood Disorders, P. C. | Bethesda, Maryland 20817 |
| Brigham & Women's Hospital | Boston, Massachusetts 02115 |
| St. John's Mercy Hospital | Washington, Missouri 63090 |
| Clinical Research Service | Scottsbluff, Nebraska 69361 |
| Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
