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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00016315 |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining combination chemotherapy with radiation therapy in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: carboplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Procedure: adjuvant therapy Procedure: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Gemcitabine, Carboplatin or Gemcitabine, Paclitaxel and Radiation Therapy Followed by Adjuvant Chemotherapy for Patients With Favorable Prognosis Inoperable Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC) |
Study Start Date: | May 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of gemcitabine and paclitaxel. Patients are sequentially assigned to 1 of 3 treatment regimens.
At 3 weeks after completion of chemoradiotherapy, all patients receive adjuvant gemcitabine IV over 30-60 minutes on days 71, 78, 92, and 99 and carboplatin IV over 30 minutes on days 71 and 92.
The first 6 patients enrolled receive regimen A to determine the safety of the initial dose of gemcitabine. After completion of regimen A, cohorts of 3-6 patients receive escalating doses of gemcitabine in regimen B (closed to accrual as of 5/13/03) until the maximum tolerated dose (MTD) is determined. In a separate sequence, cohorts of 3-6 patients receive alternating escalating doses of gemcitabine and paclitaxel in regimen C until the MTD is determined. The MTD is defined as the dose preceding that at which at least 3 of 6 patients experience dose-limiting toxicity.
Patients are followed at 3 months, 6 months, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 78 patients will be accrued for this study within 29 months.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed loco-regionally advanced non-small cell lung cancer meeting one of the following staging criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, California | |
CCOP - Bay Area Tumor Institute | |
Oakland, California, United States, 94609-3305 | |
United States, Florida | |
University of Miami Sylvester Comprehensive Cancer Center | |
Miami, Florida, United States, 33136 | |
United States, Iowa | |
Wendt Regional Cancer Center of Finley Hospital | |
Dubuque, Iowa, United States, 52001 | |
United States, New Jersey | |
Monmouth Medical Center | |
Long Branch, New Jersey, United States, 07740-6395 | |
United States, Ohio | |
Akron City Hospital | |
Akron, Ohio, United States, 44304 | |
Cancer Care Center, Incorporated | |
Salem, Ohio, United States, 44460 | |
United States, Pennsylvania | |
Dale and Frances Hughes Cancer Center | |
East Stroudsburg, Pennsylvania, United States, 18301 | |
Delaware County Memorial Hospital | |
Drexel Hill, Pennsylvania, United States, 19026 | |
Mercy Hospital of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15219 | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | |
Nashville, Tennessee, United States, 37232-5671 | |
United States, Utah | |
Cottonwood Hospital Medical Center | |
Murray, Utah, United States, 84107 | |
Dixie Regional Medical Center | |
Saint George, Utah, United States, 84770 | |
LDS Hospital | |
Salt Lake City, Utah, United States, 84143 | |
McKay-Dee Hospital Center | |
Ogden, Utah, United States, 84403 | |
Utah Valley Regional Medical Center - Provo | |
Provo, Utah, United States, 84604 | |
United States, Virginia | |
Danville Regional Medical Center | |
Danville, Virginia, United States, 24541 | |
United States, Wisconsin | |
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | |
La Crosse, Wisconsin, United States, 54601 | |
Medical College of Wisconsin Cancer Center | |
Milwaukee, Wisconsin, United States, 53226 | |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | |
Milwaukee, Wisconsin, United States, 53295 |
Study Chair: | Hak Choy, MD | Simmons Cancer Center |
Study ID Numbers: | CDR0000068622, RTOG-0017, RTOG-L-0017 |
Study First Received: | May 6, 2001 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00016315 |
Health Authority: | United States: Federal Government |
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Paclitaxel Lung Neoplasms Lung Diseases |
Carboplatin Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Respiratory Tract Neoplasms Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors |
Antimitotic Agents Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |