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Phase I Study of Irinotecan and Cisplatin in Combination With Twice Daily Thoracic Radiotherapy (45 Gy) or Once Daily Thoracic Radiotherapy (70 Gy) for Patients With Limited Stage Small Cell Lung Cancer

Phase 1
18 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

Phase I Study of Irinotecan and Cisplatin in Combination With Twice Daily Thoracic Radiotherapy (45 Gy) or Once Daily Thoracic Radiotherapy (70 Gy) for Patients With Limited Stage Small Cell Lung Cancer


- Determine the maximum tolerated dose of irinotecan administered with cisplatin and
thoracic radiotherapy (given at two different schedules) in patients with limited stage
small cell lung cancer.

- Determine the qualitative and quantitative toxicity and non-dose-limiting toxicity of
these regimens in these patients.

- Determine the reversibility of all toxic effects associated with these regimens in
these patients.

OUTLINE: This is a non-randomized, dose-escalation study of irinotecan. Patients are
assigned to 1 of 2 radiotherapy (RT) treatment groups.

- Radiotherapy:

- Group I: Patients undergo thoracic RT twice daily, 5 days a week, for 3 weeks.

- Group II: Patients undergo thoracic RT once daily, 5 days a week, for 7 weeks.

- Concurrent chemotherapy: Patients receive irinotecan IV over 60-90 minutes on days 1
and 8 and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 1
course for group I and 2 courses for group II.

- Post RT chemotherapy: Patients receive irinotecan and cisplatin as above for 3 courses
for group I and 2 courses, beginning after RT is complete, for group II.

Sequential cohorts of 6 patients per group 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 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 1 year and then 6 months for 4 years.

PROJECTED ACCRUAL: A total of 12-36 patients (6-18 per group) will be accrued for this study
within 18 months.

Inclusion Criteria


- Histologically or cytologically confirmed small cell lung cancer by one of two

- Fine needle aspiration biopsy

- Two positive sputa

- Must have limited disease as defined by all of the following:

- Stage I-IIIB

- Confined to 1 hemithorax

- No T4 tumor based on malignant pleural or pericardial effusion

- Patients with pleural effusion too small to tap under CT guidance and not
evident on chest x-ray are allowed

- No N3 disease based on contralateral hilar or contralateral supraclavicular

- Measurable or evaluable disease

- Tumor must be able to be encompassed by specified radiotherapy fields without
unacceptable risk of serious pulmonary compromise

- No complete tumor resection

- No pericardial effusion (regardless of cytology)



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 120,000/mm^3


- Bilirubin no greater than 1.5 mg/dL

- No known Gilbert's disease


- Creatinine no greater than 1.5 mg/dL


- No myocardial infarction within the past 6 months

- No symptomatic heart disease


- FEV_1 at least 1.0 L/sec

- No uncontrolled bronchospasms

- No uncompensated chronic obstructive pulmonary disease


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No pre-existing peripheral neuropathy grade 2 or greater

- No other malignancy within the past 2 years except curatively treated basal or
squamous cell skin cancer or carcinoma in situ of the bladder or cervix

- No other concurrent serious medical illness


Biologic therapy

- No prior biologic therapy


- No prior chemotherapy

Endocrine therapy

- Not specified


- No prior radiotherapy

- No concurrent intensity-modulated radiotherapy


- See Disease Characteristics


- At least 7 days since prior enzyme-inducing anti-convulsant drugs (EIACDs) (e.g.,
phenytoin, carbamazepine, or phenobarbital) if used on a regular basis for more than
2 weeks

- Less than 2 weeks of regular use of EIACDs does not require a 7-day wash-out

- At least 14 days since prior Hypericum perforatum (St. John's wort)

- No concurrent EIACDs

- No concurrent amifostine during chemoradiotherapy

- Concurrent gabapentin or other non-EIACDs allowed

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of irinotecan in combination with cisplatin and thoracic radiotherapy (45 Gy BID or 70 Gy daily) by toxicity assessment (Common Toxicity Criteria version 3.0) during acute and late toxicity

Safety Issue:


Principal Investigator

Corey J. Langer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2003

Completion Date:

Related Keywords:

  • Lung Cancer
  • limited stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



University of Chicago Cancer Research CenterChicago, Illinois  60637
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