Gemcitabine, Carboplatin or Paclitaxel Plus Radiation Therapy in Treating Patients With Stage IIIA or IIIB Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT00016315
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* Determine the maximum tolerated dose (MTD) of gemcitabine when administered with carboplatin and thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin in patients with stage IIIA or IIIB non-small cell lung cancer.
* Determine the MTD of gemcitabine and paclitaxel when administered with thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin in these patients.
OUTLINE: This is a multicenter, dose-escalation study of gemcitabine and paclitaxel. Patients are sequentially assigned to 1 of 3 treatment regimens.
* Regimen A: Patients receive gemcitabine IV over 30-60 minutes on days 1, 8, 22, 29, and 43 and thoracic radiotherapy daily 5 days a week for 7 weeks beginning on day 1.
* Regimen B (closed to accrual as of 5/13/03): Patients receive gemcitabine and thoracic radiotherapy as in regimen A and carboplatin IV over 30 minutes on days 1, 8, 22, 29, and 43.
* Regimen C: Patients receive gemcitabine and thoracic radiotherapy as in regimen A and paclitaxel IV over 1 hour on days 1, 8, 22, 29, and 43.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 9 gemcitabine hydrochloride Sequence A: Gemcitabine 750 mg/m2/week plus carboplatin 2 AUC and RT Arm 14 gemcitabine hydrochloride Sequence B: Gemcitabine 900 mg/m2/week plus paclitaxel 50 mg/m2/week and RT Arm 6 paclitaxel Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 40 mg/m2/week and RT Arm 8 radiation therapy Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 40 mg/m2/week and RT Arm 2 radiation therapy Sequence B: Gemcitabine 300 mg/m2/week plus paclitaxel 30 mg/m2/week and RT Arm 2 gemcitabine hydrochloride Sequence B: Gemcitabine 300 mg/m2/week plus paclitaxel 30 mg/m2/week and RT Arm 3 radiation therapy Sequence A: Gemcitabine 300 mg/m2/week plus carboplatin 2 AUC and RT Arm 4 gemcitabine hydrochloride Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 30 mg/m2/week and RT Arm 4 radiation therapy Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 30 mg/m2/week and RT Arm 10 radiation therapy Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 50 mg/m2/week and RT Arm 1 gemcitabine hydrochloride Sequence A: Gemcitabine 300 mg/m2/week plus radiation therapy (RT) Arm 1 radiation therapy Sequence A: Gemcitabine 300 mg/m2/week plus radiation therapy (RT) Arm 12 radiation therapy Sequence B: Gemcitabine 750 mg/m2/week plus paclitaxel 50 mg/m2/week and RT Arm 3 gemcitabine hydrochloride Sequence A: Gemcitabine 300 mg/m2/week plus carboplatin 2 AUC and RT Arm 6 gemcitabine hydrochloride Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 40 mg/m2/week and RT Arm 6 radiation therapy Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 40 mg/m2/week and RT Arm 12 gemcitabine hydrochloride Sequence B: Gemcitabine 750 mg/m2/week plus paclitaxel 50 mg/m2/week and RT Arm 8 gemcitabine hydrochloride Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 40 mg/m2/week and RT Arm 10 gemcitabine hydrochloride Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 50 mg/m2/week and RT Arm 5 gemcitabine hydrochloride Sequence A: Gemcitabine 450 mg/m2/week plus carboplatin 2 AUC and RT Arm 5 radiation therapy Sequence A: Gemcitabine 450 mg/m2/week plus carboplatin 2 AUC and RT Arm 7 gemcitabine hydrochloride Sequence A: Gemcitabine 600 mg/m2/week plus carboplatin 2 AUC and RT Arm 11 radiation therapy Sequence A: Gemcitabine 900 mg/m2/week plus carboplatin 2 AUC and RT Arm 14 radiation therapy Sequence B: Gemcitabine 900 mg/m2/week plus paclitaxel 50 mg/m2/week and RT Arm 7 radiation therapy Sequence A: Gemcitabine 600 mg/m2/week plus carboplatin 2 AUC and RT Arm 9 radiation therapy Sequence A: Gemcitabine 750 mg/m2/week plus carboplatin 2 AUC and RT Arm 11 gemcitabine hydrochloride Sequence A: Gemcitabine 900 mg/m2/week plus carboplatin 2 AUC and RT Arm 3 carboplatin Sequence A: Gemcitabine 300 mg/m2/week plus carboplatin 2 AUC and RT Arm 2 paclitaxel Sequence B: Gemcitabine 300 mg/m2/week plus paclitaxel 30 mg/m2/week and RT Arm 4 paclitaxel Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 30 mg/m2/week and RT Arm 8 paclitaxel Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 40 mg/m2/week and RT Arm 10 paclitaxel Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 50 mg/m2/week and RT Arm 5 carboplatin Sequence A: Gemcitabine 450 mg/m2/week plus carboplatin 2 AUC and RT Arm 12 paclitaxel Sequence B: Gemcitabine 750 mg/m2/week plus paclitaxel 50 mg/m2/week and RT Arm 14 paclitaxel Sequence B: Gemcitabine 900 mg/m2/week plus paclitaxel 50 mg/m2/week and RT Arm 7 carboplatin Sequence A: Gemcitabine 600 mg/m2/week plus carboplatin 2 AUC and RT Arm 9 carboplatin Sequence A: Gemcitabine 750 mg/m2/week plus carboplatin 2 AUC and RT Arm 11 carboplatin Sequence A: Gemcitabine 900 mg/m2/week plus carboplatin 2 AUC and RT
- Primary Outcome Measures
Name Time Method To determine the maximum tolerated dose of gemcitabine with paclitaxel-based chemotherapy and radiation therapy From start of treatment to 90 days To determine the maximum tolerated dose of gemcitabine with carboplatin-based chemotherapy and radiation therapy From start of treatment to 90 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Wendt Regional Cancer Center of Finley Hospital
🇺🇸Dubuque, Iowa, United States
Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States
Dale and Frances Hughes Cancer Center
🇺🇸East Stroudsburg, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
Cottonwood Hospital Medical Center
🇺🇸Murray, Utah, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
Dixie Regional Medical Center
🇺🇸Saint George, Utah, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸Milwaukee, Wisconsin, United States
University of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
Cancer Care Center, Incorporated
🇺🇸Salem, Ohio, United States
Mercy Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States