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Irinotecan and Whole-Brain Radiation Therapy in Treating Patients With Unresectable Brain Metastases From Non-Small Cell Lung Cancer



Irinotecan and Whole-Brain Radiation Therapy in Treating Patients With Unresectable Brain Metastases From Non-Small Cell Lung Cancer

For Condition: brain metastases,stage 4 non-small cell lung cancer,recurrent non-small cell lung cancer
Status: Recruiting
Sponsor(s): Norris Cotton Cancer Center , National Cancer Institute (NCI)
Synopsis: 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 and radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining irinotecan with whole-brain radiation therapy in treating patients who have unresectablebrain metastases from non-small cell lung cancer.
Details: OBJECTIVES: - Determine the efficacy of irinotecan and whole brain radiotherapy in patients with inoperable brain metastases from non-small cell lung cancer. - Determine the safety of this regimen in these patients. - Determine the response of extraneural disease in patients treated with this regimen. - Determine the disease-free survival and overall survival of patients treated with this regimen. - Determine the symptom control in patients treated with this regimen. OUTLINE: This is an open-label study. Patients receive irinotecan IV over 90 minutes on day 1. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 3 weeks after the fourth dose of chemotherapy, patients undergo whole brain irradiation once daily 5 days a week for 4 weeks. Patients with disease progression during chemotherapy start radiotherapy immediately. Patients are followed at 3 weeks and then for survival. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer (NSCLC) that does not require immediate radiotherapy - Metastases to the brain - Evaluable disease on contrast-enhanced MRI - Prior resection of brain metastases allowed provided at least 1 metastatic brain lesion is evaluable by postoperative MRI - Prior stereotactic radiosurgery for brain metastases allowed provided measurable progressive brain disease is present and there has been no prior treatment with whole brain irradiation PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - AST or ALT no greater than 5 times upper limit of normal (ULN) - Bilirubin no greater than 1.5 times ULN Renal: - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No significant cardiac disease - No uncontrolled high blood pressure - No unstable angina - No congestive heart failure - No myocardial infarction within the past 3 months - No serious cardiac arrhythmias Gastrointestinal: - No gastrointestinal abnormalities - No inability to take oral medication - No requirement for IV alimentation - No active peptic ulcer disease Other: - No hypersensitivity to irinotecan - No active infection - No other serious uncontrolled medical disorder - No dementia or significantly altered mental status that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for brain metastases - No prior irinotecan - No other concurrent chemotherapy Endocrine therapy: - Concurrent corticosteroids allowed if on a stable or decreasing dose for at least 1 week prior to enrollment - No concurrent hormonal therapy Radiotherapy: - See Disease Characteristics - Prior radiotherapy to extracerebral lesions allowed - No prior radiotherapy to brain - No other concurrent radiotherapy Surgery: - See Disease Characteristics - No prior surgical procedures affecting absorption - Prior thoracic surgery allowed Other: - No other concurrent investigational anticancer agents
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
CamiloFadul,  Study Chair,  Norris Cotton Cancer Center

Neurological Research Center, Inc. *Recruiting*
Bennington,  Vermont,  05201
United States
Recruiting Michael  Glantz 802-447-7577

Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon,  New Hampshire,  03756-0002
United States
Recruiting Camilo  Fadul 603-650-6312


Additional Information:
Study ID Numbers:  CDR0000069323;  DMS-0119,NCI-G02-2062
Study Start Date: 
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036803

Other Brain Metastases Studies:
1. Radiation Therapy Followed by Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Malignant Melanoma

2. Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain

3. Radiation Therapy With or Without Temozolomide in Treating Patients With Non-Small Cell Lung Cancer That is Metastatic to the Brain

4. Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain

5. Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain

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