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Phase I Trial of Radical Thoracic Radiation, Weekly CPT-11 (Irinotecan) and Cisplatin in Locally Advanced Non-Small Cell Lung Carcinoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Phase I Trial of Radical Thoracic Radiation, Weekly CPT-11 (Irinotecan) and Cisplatin in Locally Advanced Non-Small Cell Lung Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Corey J. Langer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068803

NCT ID:

NCT00022308

Start Date:

January 1999

Completion Date:

September 2006

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

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