Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

NCT00022308 | Completed Phase 1

• 4 other identifiers: CDR0000068803P30CA006927FCCC-98020NCI-G01-1995
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 8

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.

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

Interventions

cisplatin DRUG

irinotecan hydrochloride DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (8)

South Jersey Regional Cancer Center

Millville, New Jersey, 08332, United States

Location

Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County

Mount Holly, New Jersey, 08060, United States

Location

Riverview Medical Center - Booker Cancer Center

Red Bank, New Jersey, 07701, United States

Location

Community Medical Center

Toms River, New Jersey, 08755, United States

Location

St. Francis Medical Center

Trenton, New Jersey, 08629, United States

Location

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Related Publications (1)

• 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.

  PMID: 17410043 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Irinotecan; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Camptothecin; Alkaloids; Heterocyclic Compounds; Therapeutics

Study Officials

• Corey J. Langer, MD

  Fox Chase Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2001
• First Posted: February 27, 2004
• Study Start: January 1, 1999
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: September 2, 2013

Record last verified: 2013-08

Locations

US (8)