Chemotherapy Combined With Radiation Therapy in Treating Patients With 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 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.
Checked against the public recordLast updated Nov 17, 2015 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Radiation Therapy Oncology Group
- Interventions being studied
- Drug: cisplatin; Drug: irinotecan hydrochloride; Radiation: radiation therapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama
- Providence Saint Joseph Medical Center - BurbankBurbank, California
- Saint Rose HospitalHayward, California
- Valley Memorial HospitalLivermore, California
- Highland General Hospital at St. George's University School of MedicineOakland, California
- CCOP - Bay Area Tumor InstituteOakland, California
- Summit Medical CenterOakland, California
- J.C. Robinson, M.D. Regional Cancer CenterSan Pablo, California
- CCOP - Christiana Care Health ServicesNewark, Delaware
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida
- University of Florida Shands Cancer CenterGainesville, Florida
- Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 17, 2015. Always confirm current availability with the study team.