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Home > "G" Clinical Trials Conditions > Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer  Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
For Condition: stage 3A non-small cell lung cancer,adenosquamous cell lung cancer,squamous cell lung cancer,stage 3B non-small cell lung cancer,large cell lung cancer,adenocarcinoma of the lung
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Comprehensive Cancer Center of Wake Forest University
Synopsis: 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 radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to compare the effectiveness of gemcitabine with radiation therapy alone or following two-drug combination chemotherapy in treating patients with stage III non-small cell lung cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy alone or following 2 cycles of induction chemotherapy in patients with Stage IIIA or IIIB non-small cell lung cancer. II. Assess the toxicity of concurrent thoracic radiation and gemcitabine in these patients. III. Determine the effectiveness of concurrent radiation and gemcitabine by determining the complete response rate, partial response rate, time to recurrence, pattern of recurrence, and overall survival in a cohort of these patients. PROTOCOL OUTLINE: This is an alternating two arm, dose escalation, multicenter study. Arm I: Patients receive twice-weekly gemcitabine as a 30 minute infusion. Concurrent radiation therapy is administered 5 days a week for 6 weeks. Arm II: Patients receive 2 cycles of induction chemotherapy consisting of gemcitabine as a 30 minute infusion on day 1 and 8 and cisplatin IV over 1 hour on day 1. Each cycle is 21 days. Patients then receive gemcitabine and radiation therapy as in arm I. Cohorts of 3 patients are enrolled into each treatment arm at each dose level of gemcitabine. Toxicity for each arm is assessed independently. Once dose limiting toxicity (DLT) is observed at any dose level, 3 more patients are enrolled at the same dose level. The maximum tolerated dose (MTD) is defined as the dose at which no more than 1 of 6 patients experiences grade 4 toxicity, or no more than 4 of 6 patients experience grade 3 or worse toxicity (DLT). After the MTD is determined for each treatment arm, additional patients are treated at that dose level for the phase II portion of the study. Patients are followed every 3 months for 2 years, then every 4 months for the next 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: There will be approximately 24-48 patients accrued into this study within 1-2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed Stage IIIA or IIIB non-small cell lung cancer that is unicentric and inoperable; Squamous cell carcinoma; Adenocarcinoma; Bronchoalveolar carcinoma; Large cell anaplastic carcinoma; Non-small cell lung cancer not otherwise specified - Tumors may be multifocal if all of disease is believed to be result of direct spread - Disease must be fully accessible by radiotherapy ports for the entire prescribed dose - No supraclavicular nodes or diffuse pleural involvement - No contralateral hilar disease or an exudative, bloody, or cytologically malignant effusion - Measurable disease for phase II of this study --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior thoracic radiotherapy; Concurrent radiotherapy to other anatomic sites allowed - Surgery: Not specified --Patient Characteristics-- - Age: Any age - Performance status: ECOG 0-2 - Life expectancy: At least 1 year - Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin greater than 10 g/dL - Hepatic: Bilirubin no greater than 2.0 mg/dL - Renal: BUN no greater than 1.5 times normal; Creatinine no greater than 1.5 times normal - Pulmonary: FEV1 no greater than 1 liter except if tumor has negatively impacted pulmonary function - Other: No other serious medical or psychiatric illness; No prior lung cancer except if free of disease for more than 3 years; No other prior malignancy except nonmelanoma skin cancer or if free of disease for more than 1 year; Not pregnant or nursing; Negative pregnancy test
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ArthurBlackstock, Study Chair, Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Additional Information:
Study ID Numbers: CDR0000066052; CCCWFU-62197,NCI-G98-1386
Study Start Date: January 1998
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003202
Other Adenocarcinoma Of The Lung Studies:
1. Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
2. Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery
3. Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
4. Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
5. Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
Related Studies:
Other adenocarcinoma of the lung Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
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