NCT00006487
S0004: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-stage Small Cell Lung Cancer
PHASE1
COMPLETED
NCT00006487
INTERVENTIONAL
A Phase I Study Of Tirapazamine/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer
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.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed limited stage small cell lung cancer (SCLC)
* No malignant pericardial or pleural effusions, including any of the following:
* Cytologically positive effusions
* Exudative effusions not attributable to other etiologies
* No brain metastases
* Disease (measurable or non-measurable) must be present outside the area of prior surgical resection
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 2 times ULN
* Alkaline phosphatase no greater than 2 times ULN
Renal:
* Creatinine no greater than ULN OR
* Creatinine clearance at least 60 mL/min
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No symptomatic sensory neuropathy grade 1 or greater
* No other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other stage I or II cancer in complete remission
* No other medical illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior biologic therapy for SCLC
Chemotherapy:
* No prior systemic chemotherapy for SCLC
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior thoracic radiotherapy for SCLC
Surgery:
* See Disease Characteristics
* At least 2 weeks since prior thoracic or other major surgery and recovered
Lung Cancer
- TREATMENT
-
- Type: DRUG
- Name: cisplatin
- Description: 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.
- Arm Group Labels: chemo/RT with tirapazamine
-
- Type: DRUG
- Name: etoposide
- Description: 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.
- Arm Group Labels: chemo/RT with tirapazamine
-
- Type: DRUG
- Name: tirapazamine
- Description: During induction: 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 During consolidation: 330 mg/ m2, IV Day 1 only at approximately Week 11, Week 14. 1 hour infusion.
- Arm Group Labels: chemo/RT with tirapazamine
-
- Type: RADIATION
- Name: radiation therapy
- Description: 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.
- Arm Group Labels: chemo/RT with tirapazamine
- SWOG Cancer Research Network