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A Phase II Study of Irinotecan (CPT-11) and Docetaxel (Taxotere) in Patients With Recurrent Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase II Study of Irinotecan (CPT-11) and Docetaxel (Taxotere) in Patients With Recurrent Non-Small Cell Lung Cancer

OBJECTIVES: I. Evaluate the response rate of previously treated patients with recurrent
non-small cell lung cancer after treatment with irinotecan and docetaxel. II. Determine the
toxicity of this regimen in these patients. III. Determine the overall survival in this
patient population.

OUTLINE: Patients receive irinotecan IV over 90 minutes immediately followed by docetaxel IV
over 60 minutes on day 1. Treatment is repeated every 3 weeks for 6 courses in the absence
of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5
years or until death.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 24 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung
cancer (NSCLC) Reconfirmation of NSCLC required only if complete response for greater than
1 year Measurable or evaluable disease Tumor shrinkage or stability for at least 4 weeks
on initial chemotherapy CNS metastases allowed, if symptoms controlled for greater than 8
weeks after surgery or radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-1 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin normal AST no greater than 2 times upper limit of
normal (ULN) Renal: Creatinine no greater than 2.5 times ULN Cardiovascular: No New York
Heart Association class III or IV heart disease Other: No active infection At least 5
years since any other prior malignancy except curatively treated basal or squamous cell
skin cancer, carcinoma in situ, or other cancers No grade 2 or worse peripheral neuropathy
No uncontrolled diabetes mellitus No other serious underlying disease Not pregnant or
nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No greater than 1 prior NSCLC chemotherapy regimen, excluding low dose
cisplatin as a radiosensitizer No prior irinotecan or docetaxel At least 4 weeks since
prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease
Characteristics At least 4 weeks since prior radiotherapy No prior radiotherapy to greater
than 25% of bone marrow Surgery: See Disease Characteristics Other: No concurrent
phenytoin, phenobarbital, or other anticonvulsants

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Alex A. Adjei, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

October 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Duluth Duluth, Minnesota  55805
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
CentraCare Clinic Saint Cloud, Minnesota  56303
Quain & Ramstad Clinic, P.C. Bismarck, North Dakota  58501
CCOP - Merit Care Hospital Fargo, North Dakota  58122
Altru Health Systems Grand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080