Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00004093|
Recruitment Status : Terminated (Original Principal Investigator left the institution.)
First Posted : November 4, 2003
Last Update Posted : June 6, 2012
RATIONALE: Drugs used in chemotherapy use 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 chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage III non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: carboplatin Drug: Gemcitabine Drug: paclitaxel Drug: vinorelbine Radiation: radiation therapy Drug: Navelbine Drug: Taxol||Phase 1 Phase 2|
OBJECTIVES: I. Determine the feasibility of the concurrent chemoradiotherapy regimen of paclitaxel and vinorelbine with standard chest radiotherapy in patients with locally advanced non-small cell lung cancer. II. Determine the maximum tolerated dose and dose limiting toxicities of this regimen in this patient population. III. Determine the radiologic response rate of induction chemotherapy with carboplatin and gemcitabine in this patient population. IV. Evaluate the pathologic response rate in patients undergoing resection. V. Evaluate the time to progression, overall survival, and quality of life in this patient population.
OUTLINE: This is a dose escalation study of vinorelbine. Patients receive induction chemotherapy consisting of carboplatin IV over 30 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses. At 2 weeks following completion of induction chemotherapy, patients receive vinorelbine IV over 10 minutes followed by paclitaxel IV over 60 minutes weekly and radiotherapy daily for 5 consecutive days a week on weeks 1-6. Following initial induction chemotherapy, patients with stable or regressive disease may receive an additional 2-4 courses of carboplatin and gemcitabine at investigator's discretion. At approximately 2-6 weeks following completion of chemoradiotherapy, patients with resectable/operable disease undergo surgical resection. Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose limiting toxicity. Quality of life is assessed in all patients. Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 38-47 patients will be accrued for this study within 12-18 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I-II Study of Induction Chemotherapy With Carboplatin and Gemcitabine, Followed by Chemoradiotherapy With Paclitaxel and Vinorelbine for Patients With Locally Advanced Non-Small Cell Lung Cancer|
|Study Start Date :||August 1999|
|Actual Primary Completion Date :||February 2002|
|Actual Study Completion Date :||March 2002|
- Drug: carboplatin
Carboplatin will be dosed at a target AUC of 5, and will be given on day 1 of each cycle
- Drug: Gemcitabine
Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of each 21-day cycle of induction chemo (following carboplatin on day 1).
- Drug: paclitaxel
Paclitaxel will be given on day 1 of each week for 6 weeks at a dose of 50 mg/m2.
- Drug: vinorelbine
Vinorelbine will be given on day 1 of each week for 6 weeks at a starting dose of 10 mg/m2, escalating up to 15 mg/m2 if no dose limiting toxicities are observed.
- Radiation: radiation therapy
Radiation will be given at a dose ranging between 45 to 66 Gy, depending on patient-specific characteristics.
- Drug: Navelbine
Navelbine will be administered at a dose of 10-15 mg/m2 in 100 cc NS to be administered over 10 minutes I.V. (one dose weekly during radiation therapy)
- Drug: Taxol
Taxol will be administered at a dose of 50 mg/m2 in 250 cc of NS or D5W over 60 minutes, following Navelbine (one dose weekly during radiation therapy)
- Maximum tolerated dose of the combination therapies [ Time Frame: After each cycle of therapy ]Toxicity will be assessed for each patient after each cycle of therapy. The maximum tolerated dose (MTD) will be the dose level prior to the dose in which greater than one-third of patients experience a dose-limiting toxicity.
- Determine the radiologic response rate of the combined study therapies [ Time Frame: After every 2 cycles of study therapy ]Patients will have a radiographic work-up (in the form of a chest CT) after every 2 cycles of therapy to assess tumor response to the study therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004093
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Study Chair:||Gregory A. Masters, MD||Robert H. Lurie Cancer Center|