S0004: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-stage Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00006487|
Recruitment Status : Completed
First Posted : April 2, 2004
Last Update Posted : October 4, 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 more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: cisplatin Drug: etoposide Drug: tirapazamine Radiation: radiation therapy||Phase 1|
- Determine the feasibility of tirapazamine, cisplatin, and etoposide concurrently with radiotherapy in patients with limited stage small cell lung cancer.
- Determine the toxicities of this treatment regimen in these patients.
- Determine the response rate in these patients treated with this regimen.
OUTLINE: Patients are assigned to one of two induction therapy arms.
- Arm I: Patients receive induction chemotherapy consisting of low-dose tirapazamine IV over 1 hour and cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients also undergo radiotherapy concurrently with chemotherapy 5 consecutive days a week for 7 weeks beginning on day 1.
- Arm II: Patients receive induction chemotherapy consisting of high-dose tirapazamine, cisplatin, etoposide, and radiotherapy as in arm I.
Patients with stable or responding disease then receive consolidation therapy consisting of tirapazamine IV over 1 hour and cisplatin IV over 1 hour on day 1 of weeks 11 and 14 and etoposide IV over 1 hour on days 1-3 of weeks 11 and 14.
Patients are followed every 2 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study Of Tirapazamine/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer|
|Study Start Date :||October 2000|
|Actual Primary Completion Date :||July 2004|
|Actual Study Completion Date :||July 2004|
Active Comparator: chemo/RT with tirapazamine
induction and consolidation: cisplatin, etoposide, tirapazamine, radiation therapy
During induction: 50 mg/m2/day, IV on Days 1, 8, 29, 36. 1 hour infusion
During consolidation: 60 mg/m2, IV on Day 1 only at approximately Week 11, Week 14. 1 hour infusion.
Other Name: platinolDrug: etoposide
During induction: 50 mg/m2/day, IV on Days 1 - 5, 29 - 33. 1 hour infusion
During consolidation: 120 mg/m2, IV on Days 1, 2 and 3 at approximately Week 11, Week 14. 1 hour infusion.
Other Name: VP-16Drug: tirapazamine
Radiation: radiation therapy
Phase I low dose: 260 mg/m2/day, IV on Days 1, 8, 29, 36. 1 hour infusion
Phase II high dose: 330 mg/m2/day, IV on Days 1, 8, 29, 36 1 hour infusion
330 mg/ m2, IV Day 1 only at approximately Week 11, Week 14. 1 hour infusion.
Radiotherapy should begin within 1 - 3 hours after completion of TPZ infusion on Day 1 of Cycle 1 of induction chemotherapy as outlined above. Computed tomography based treatment planning is strongly recommended.The primary tumor, adjacent mediastinum and other targeted lymph nodes shall receive 4,500 cGy in 25 fractions, five days/week at 180 cGy daily. A 1,600 cGy boost to areas of gross disease will be delivered through reduced off-spinal cord fields in eight fractions, five days/week at 200 cGy daily.
- Feasibility and Toxicity [ Time Frame: toxicity is assessed weekly ]If ten or more patients experience either Grade 3 or greater esophagitis or pneumonitis at any dose level, the trial will be stopped. Nine or fewer patients experiencing either of these toxicities will be evidence that the dose can be escalated to the next level.
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): NCT00006487
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|Study Chair:||Quynh-Thu X. Le, MD||Stanford University|