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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 Center Chicago, Illinois  60637
Duke Comprehensive Cancer Center Durham, North Carolina  27710
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Providence Saint Joseph Medical Center - Burbank Burbank, California  91505
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
Albert Einstein Cancer Center Philadelphia, Pennsylvania  19141
CCOP - Greenville Greenville, South Carolina  29615
Dixie Regional Medical Center Saint George, Utah  84770
LDS Hospital Salt Lake City, Utah  84143
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
Monmouth Medical Center Long Branch, New Jersey  07740-6395
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030
Comprehensive Cancer Center at University of Alabama at Birmingham Birmingham, Alabama  35294
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer Program Miami, Florida  33176
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Greenville Hospital System Cancer Center Greenville, South Carolina  29605
William Beaumont Hospital - Royal Oak Campus Royal Oak, Michigan  48073
Fox Chase Virtua Health Cancer Program - Marlton Marlton, New Jersey  08053
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Cottonwood Hospital Medical Center Murray, Utah  84107
McKay-Dee Hospital Center Ogden, Utah  84403
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
Memorial Cancer Institute at Memorial Regional Hospital Hollywood, Florida  33021
Summit Medical Center Oakland, California  94609
Saint Rose Hospital Hayward, California  94545
Highland General Hospital at St. George's University School of Medicine Oakland, California  94602
J.C. Robinson, M.D. Regional Cancer Center San Pablo, California  94806
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale, Florida  33308
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter, Florida  33458
Wayne Radiation Oncology Goldsboro, North Carolina  27534
Wilson Medical Center Wilson, North Carolina  27893-3428
Delaware County Regional Cancer Center at Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
Bon Secours St. Francis Health System Greenville, South Carolina  29601
Valley Memorial Hospital Livermore, California  94550
Wendt Regional Cancer Center at Finley Hospital Dubuque, Iowa  52001
AtlantiCare Regional Medical Center Pomona, New Jersey  08240
Tucker Center for Cancer Care at Orange Regional Medical Center Middletown, New York  10940-4199
Mercy Cancer Institute at Mercy Hospital Pittsburgh, Pennsylvania  15219
Sarah Cannon Cancer Center at Parkridge Medical Center Chattanooga, Tennessee  37404-3285