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)
Overview
- Phase
- Phase 1
- Intervention
- carboplatin
- Conditions
- Lung Cancer
- Sponsor
- Radiation Therapy Oncology Group
- Enrollment
- 35
- Locations
- 19
- Primary Endpoint
- To determine the maximum tolerated dose of gemcitabine with paclitaxel-based chemotherapy and radiation therapy
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm 9
Sequence A: Gemcitabine 750 mg/m2/week plus carboplatin 2 AUC and RT
Intervention: carboplatin
Arm 1
Sequence A: Gemcitabine 300 mg/m2/week plus radiation therapy (RT)
Intervention: gemcitabine hydrochloride
Arm 1
Sequence A: Gemcitabine 300 mg/m2/week plus radiation therapy (RT)
Intervention: radiation therapy
Arm 2
Sequence B: Gemcitabine 300 mg/m2/week plus paclitaxel 30 mg/m2/week and RT
Intervention: gemcitabine hydrochloride
Arm 2
Sequence B: Gemcitabine 300 mg/m2/week plus paclitaxel 30 mg/m2/week and RT
Intervention: paclitaxel
Arm 2
Sequence B: Gemcitabine 300 mg/m2/week plus paclitaxel 30 mg/m2/week and RT
Intervention: radiation therapy
Arm 3
Sequence A: Gemcitabine 300 mg/m2/week plus carboplatin 2 AUC and RT
Intervention: carboplatin
Arm 3
Sequence A: Gemcitabine 300 mg/m2/week plus carboplatin 2 AUC and RT
Intervention: gemcitabine hydrochloride
Arm 3
Sequence A: Gemcitabine 300 mg/m2/week plus carboplatin 2 AUC and RT
Intervention: radiation therapy
Arm 4
Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 30 mg/m2/week and RT
Intervention: gemcitabine hydrochloride
Arm 4
Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 30 mg/m2/week and RT
Intervention: paclitaxel
Arm 4
Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 30 mg/m2/week and RT
Intervention: radiation therapy
Arm 6
Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 40 mg/m2/week and RT
Intervention: gemcitabine hydrochloride
Arm 6
Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 40 mg/m2/week and RT
Intervention: paclitaxel
Arm 6
Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 40 mg/m2/week and RT
Intervention: radiation therapy
Arm 8
Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 40 mg/m2/week and RT
Intervention: gemcitabine hydrochloride
Arm 8
Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 40 mg/m2/week and RT
Intervention: paclitaxel
Arm 12
Sequence B: Gemcitabine 750 mg/m2/week plus paclitaxel 50 mg/m2/week and RT
Intervention: paclitaxel
Arm 8
Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 40 mg/m2/week and RT
Intervention: radiation therapy
Arm 10
Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 50 mg/m2/week and RT
Intervention: gemcitabine hydrochloride
Arm 10
Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 50 mg/m2/week and RT
Intervention: paclitaxel
Arm 10
Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 50 mg/m2/week and RT
Intervention: radiation therapy
Arm 12
Sequence B: Gemcitabine 750 mg/m2/week plus paclitaxel 50 mg/m2/week and RT
Intervention: gemcitabine hydrochloride
Arm 12
Sequence B: Gemcitabine 750 mg/m2/week plus paclitaxel 50 mg/m2/week and RT
Intervention: radiation therapy
Arm 14
Sequence B: Gemcitabine 900 mg/m2/week plus paclitaxel 50 mg/m2/week and RT
Intervention: gemcitabine hydrochloride
Arm 14
Sequence B: Gemcitabine 900 mg/m2/week plus paclitaxel 50 mg/m2/week and RT
Intervention: paclitaxel
Arm 14
Sequence B: Gemcitabine 900 mg/m2/week plus paclitaxel 50 mg/m2/week and RT
Intervention: radiation therapy
Arm 5
Sequence A: Gemcitabine 450 mg/m2/week plus carboplatin 2 AUC and RT
Intervention: carboplatin
Arm 5
Sequence A: Gemcitabine 450 mg/m2/week plus carboplatin 2 AUC and RT
Intervention: gemcitabine hydrochloride
Arm 5
Sequence A: Gemcitabine 450 mg/m2/week plus carboplatin 2 AUC and RT
Intervention: radiation therapy
Arm 7
Sequence A: Gemcitabine 600 mg/m2/week plus carboplatin 2 AUC and RT
Intervention: carboplatin
Arm 7
Sequence A: Gemcitabine 600 mg/m2/week plus carboplatin 2 AUC and RT
Intervention: gemcitabine hydrochloride
Arm 7
Sequence A: Gemcitabine 600 mg/m2/week plus carboplatin 2 AUC and RT
Intervention: radiation therapy
Arm 9
Sequence A: Gemcitabine 750 mg/m2/week plus carboplatin 2 AUC and RT
Intervention: gemcitabine hydrochloride
Arm 9
Sequence A: Gemcitabine 750 mg/m2/week plus carboplatin 2 AUC and RT
Intervention: radiation therapy
Arm 11
Sequence A: Gemcitabine 900 mg/m2/week plus carboplatin 2 AUC and RT
Intervention: carboplatin
Arm 11
Sequence A: Gemcitabine 900 mg/m2/week plus carboplatin 2 AUC and RT
Intervention: gemcitabine hydrochloride
Arm 11
Sequence A: Gemcitabine 900 mg/m2/week plus carboplatin 2 AUC and RT
Intervention: radiation therapy
Outcomes
Primary Outcomes
To determine the maximum tolerated dose of gemcitabine with paclitaxel-based chemotherapy and radiation therapy
Time Frame: From start of treatment to 90 days
To determine the maximum tolerated dose of gemcitabine with carboplatin-based chemotherapy and radiation therapy
Time Frame: From start of treatment to 90 days