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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
N/A
Open (Enrolling)
Both
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


OBJECTIVES:

- 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


DISEASE CHARACTERISTICS:

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

- 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
involvement

- 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)

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

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

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

Hepatic

- Bilirubin no greater than 1.5 mg/dL

- No known Gilbert's disease

Renal

- Creatinine no greater than 1.5 mg/dL

Cardiovascular

- No myocardial infarction within the past 6 months

- No symptomatic heart disease

Pulmonary

- FEV_1 at least 1.0 L/sec

- No uncontrolled bronchospasms

- No uncompensated chronic obstructive pulmonary disease

Other

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior biologic therapy

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy

- No concurrent intensity-modulated radiotherapy

Surgery

- See Disease Characteristics

Other

- 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
period

- 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:

Interventional

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:

Yes

Principal Investigator

Corey J. Langer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000269348

NCT ID:

NCT00059761

Start Date:

March 2003

Completion Date:

Related Keywords:

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

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
CCOP - GreenvilleGreenville, South Carolina  29615
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer ProgramMiami, Florida  33176
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Greenville Hospital System Cancer CenterGreenville, South Carolina  29605
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Fox Chase Virtua Health Cancer Program - MarltonMarlton, New Jersey  08053
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida  33021
Summit Medical CenterOakland, California  94609
Saint Rose HospitalHayward, California  94545
Highland General Hospital at St. George's University School of MedicineOakland, California  94602
J.C. Robinson, M.D. Regional Cancer CenterSan Pablo, California  94806
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Delaware County Regional Cancer Center at Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Valley Memorial HospitalLivermore, California  94550
Wendt Regional Cancer Center at Finley HospitalDubuque, Iowa  52001
AtlantiCare Regional Medical CenterPomona, New Jersey  08240
Tucker Center for Cancer Care at Orange Regional Medical CenterMiddletown, New York  10940-4199
Mercy Cancer Institute at Mercy HospitalPittsburgh, Pennsylvania  15219
Sarah Cannon Cancer Center at Parkridge Medical CenterChattanooga, Tennessee  37404-3285