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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Fox Chase Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00022308
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: irinotecan hydrochloride
Procedure: radiation therapy
Phase I

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Cisplatin    Irinotecan    Irinotecan hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Trial of Radical Thoracic Radiation, Weekly CPT-11 (Irinotecan) and Cisplatin in Locally Advanced Non-Small Cell Lung Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   January 1999

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022308

Locations
United States, New Jersey
Community Medical Center    
      Toms River, New Jersey, United States, 08755
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County    
      Mount Holly, New Jersey, United States, 08060
Riverview Medical Center - Booker Cancer Center    
      Red Bank, New Jersey, United States, 07701
South Jersey Regional Cancer Center    
      Millville, New Jersey, United States, 08332
St. Francis Medical Center    
      Trenton, New Jersey, United States, 08629
United States, Pennsylvania
Delaware County Memorial Hospital    
      Drexel Hill, Pennsylvania, United States, 19026
Fox Chase Cancer Center    
      Philadelphia, Pennsylvania, United States, 19111
Reading Hospital and Medical Center    
      Reading, Pennsylvania, United States, 19612-6052

Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Corey J. Langer, MD     Fox Chase Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000068803, FCCC-98020, NCI-G01-1995
First Received:   August 10, 2001
Last Updated:   October 12, 2008
ClinicalTrials.gov Identifier:   NCT00022308
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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  

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Irinotecan
Carcinoma, Non-Small-Cell Lung
Camptothecin
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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