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Topotecan/Paclitaxel Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer: A Phase II Study

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Topotecan/Paclitaxel Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer: A Phase II Study

OBJECTIVES: I. Determine the complete response rate to 2 courses of paclitaxel and topotecan
followed by consolidation chemoradiotherapy in patients with limited stage small cell lung
cancer. II. Determine the toxic effects of this regimen in this patient population. III.
Describe the pattern of relapse, documenting carefully the location of relapse with respect
to the original disease volume and the radiation treatment field in these patients. IV.
Determine the overall and failure free survival of these patients.

OUTLINE: Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1.
Filgrastim (G-CSF) is administered subcutaneously every day starting on day 6 until blood
counts recover. The course is repeated once beginning on day 22. After restaging, patients
begin thoracic radiotherapy daily, five days per week, for 6-7 weeks. On the same day that
radiotherapy begins, patients receive carboplatin IV over 1 hour (day 43) and etoposide IV
over 1 hour daily for 3 days (days 43-45). The consolidation chemotherapy is repeated every
21 days for a total of 3 courses. Patients with stable or responding disease undergo
prophylactic cranial irradiation. Patients are followed at least every 3 months for 2 years,
every 6 months for 3 years, and then at least every year.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 15-18

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed limited stage small
cell lung cancer Includes disease restricted to one hemithorax with regional lymph node
metastases, including hilar, ipsilateral and contralateral mediastinal lymph nodes
Clinically suspected or confirmed supraclavicular lymph node metastases and pleural
effusions that are visible on plain chest radiographs, whether cytologically positive or
not, are not eligible Unidimensionally or bidimensionally measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2 times upper limit of
normal (ULN) Renal: Creatinine no greater than ULN Other: Not pregnant or nursing Fertile
patients must use effective contraception No concurrent active second malignancy except
nonmelanoma skin cancer (i.e., completed therapy and considered to be at less than 30%
risk of relapse)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for small cell lung cancer No other concurrent chemotherapy Endocrine
therapy: No concurrent steroids except for adrenal failure No concurrent hormones except
for nondisease related conditions (e.g., insulin for diabetes) No concurrent dexamethasone
except for intermittent use as an antiemetic or as an adjunct to prophylactic cranial
irradiation Radiotherapy: No prior mediastinal radiotherapy Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Alan P. Lyss, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Missouri Baptist Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 1999

Completion Date:

March 2006

Related Keywords:

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



Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Vincent T. Lombardi Cancer Research Center, Georgetown University Washington, District of Columbia  20007
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Medical University of South Carolina Charleston, South Carolina  29425-0721
Rhode Island Hospital Providence, Rhode Island  02903
Vermont Cancer Center Burlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
Veterans Affairs Medical Center - Birmingham Birmingham, Alabama  35233
Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
Dana-Farber Cancer Institute Boston, Massachusetts  02115
North Shore University Hospital Manhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Memphis Memphis, Tennessee  38104
Veterans Affairs Medical Center - Richmond Richmond, Virginia  23249
University of Illinois at Chicago Health Sciences Center Chicago, Illinois  60612
Veterans Affairs Medical Center - Togus Togus, Maine  04330
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Missouri Baptist Cancer Center St. Louis, Missouri  63131