Clinical trial NCT00022308: Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Official title: Phase I Trial of Radical Thoracic Radiation, Weekly CPT-11 (Irinotecan) and Cisplatin in Locally Advanced Non-Small Cell Lung Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Cancer
Keywords: stage II non-small cell lung cancer
recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-02-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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 effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced non-small cell lung cancer.

Detailed description: OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan when administered with cisplatin and radiotherapy in patients with locally advanced non-small cell lung carcinoma. II. Determine the toxic effects, especially acute and long-term esophagitis and pneumonitis, of this regimen in these patients. III. Determine the response rate, duration to progression, and sites of relapse in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of irinotecan. Patients receive irinotecan IV over 90 minutes and cisplatin over 1 hour on day 1. Patients also undergo radiotherapy once daily on days 1-5. Treatment repeats every 7 days for 7 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 3-27 patients will be accrued for this study within 3 years.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IIIB or bulky stage IIIA not amenable to surgical resection Medically inoperable stage II or non-bulky stage IIIA Locally recurrent disease following surgery that is not amenable to further surgical resection No small cell carcinoma or mixed cytology No disease beyond radiation portal (T4 tumors with documented multifocal malignant pleural involvement or extension of supraclavicular nodal disease to cervical chain) No pleural effusion Pleural effusions visible on CT scan but not on chest x-ray that are inaccessible to thoracentesis or are cytologically negative are allowed Ineligible for enrollment on protocol RTOG 93-09

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL No known Gilbert's disease Renal: Creatinine no greater than 1.5 mg/dL Calcium less than 12.0 mg/dL Cardiovascular: No symptomatic cardiovascular disease No active angina No congestive heart failure requiring active therapy No uncontrolled arrhythmias No myocardial infarction within the past 6 months Pulmonary: FEV1 at least 1.0 L unless cleared by radiation oncologist Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception for 3 months before study, during study, and for 3 months after study HIV negative No other concurrent active or invasive malignancy except nonmelanoma skin cancer Less than 10% unintended weight loss within 3 months of diagnosis No other concurrent medical condition that would preclude study No social situation or psychiatric disorder that would preclude study No active or uncontrolled infection No history of seizures No uncontrolled diabetes mellitus (random blood sugar at least 250 mg/dL)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for NSCLC No prior irinotecan or topotecan Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for NSCLC No prior radiotherapy to the chest Surgery: See Disease Characteristics Other: No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Millville
country: United States
facility: South Jersey Regional Cancer Center
state: New Jersey
city: Mount Holly
country: United States
facility: Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
state: New Jersey
city: Red Bank
country: United States
facility: Riverview Medical Center - Booker Cancer Center
state: New Jersey
city: Toms River
country: United States
facility: Community Medical Center
state: New Jersey
city: Trenton
country: United States
facility: St. Francis Medical Center
state: New Jersey
city: Drexel Hill
country: United States
facility: Delaware County Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Reading
country: United States
facility: Reading Hospital and Medical Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Corey J. Langer, MD
role: STUDY_CHAIR
References:
citation: Langer CJ, Somer R, Litwin S, Feigenberg S, Movsas B, Maiale C, Sherman E, Millenson M, Nicoloau N, Huang C, Treat J. Phase I study of radical thoracic radiation, weekly irinotecan, and cisplatin in locally advanced non-small cell lung carcinoma. J Thorac Oncol. 2007 Mar;2(3):203-9. doi: 10.1097/JTO.0b013e318031cd3c.