Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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 with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effect on the body when combining irinotecan and cisplatin with radiation therapy in treating patients who have limited-stage small cell lung cancer that could not be completely removed during surgery.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Cisplatin; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed small cell lung cancer by one of two methods:

• Fine needle aspiration biopsy

• Two positive sputa

• Must have limited disease as defined by all of the following:

• Stage I-IIIB

• Confined to 1 hemithorax

• No T4 tumor based on malignant pleural or pericardial effusion

• Patients with pleural effusion too small to tap under CT guidance and not evident on chest x-ray are allowed

• No N3 disease based on contralateral hilar or contralateral supraclavicular involvement

• Measurable or evaluable disease

• Tumor must be able to be encompassed by specified radiotherapy fields without unacceptable risk of serious pulmonary compromise

• No complete tumor resection

• No pericardial effusion (regardless of cytology)

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count at least 1,500/mm^3

• Platelet count at least 120,000/mm^3

Hepatic

• Bilirubin no greater than 1.5 mg/dL

• No known Gilbert's disease

Renal

• Creatinine no greater than 1.5 mg/dL

Cardiovascular

• No myocardial infarction within the past 6 months

• No symptomatic heart disease

Pulmonary

• Forced expiratory volume (FEV)_1 at least 1.0 L/sec

• No uncontrolled bronchospasms

• No uncompensated chronic obstructive pulmonary disease

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No pre-existing peripheral neuropathy grade 2 or greater

• No other malignancy within the past 2 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the bladder or cervix

• No other concurrent serious medical illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic therapy

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

• No concurrent intensity-modulated radiotherapy

Surgery

• See Disease Characteristics

Other

• At least 7 days since prior enzyme-inducing anti-convulsant drugs (EIACDs) (e.g., phenytoin, carbamazepine, or phenobarbital) if used on a regular basis for more than 2 weeks

• Less than 2 weeks of regular use of EIACDs does not require a 7-day wash-out period

• At least 14 days since prior Hypericum perforatum (St. John's wort)

• No concurrent EIACDs

• No concurrent amifostine during chemoradiotherapy

• Concurrent gabapentin or other non-EIACDs allowed