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Randomized Phase II Study of Docetaxel and Gemcitabine for Stage IIIB/IV Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Randomized Phase II Study of Docetaxel and Gemcitabine for Stage IIIB/IV Non-Small Cell Lung Cancer

OBJECTIVES: I. Evaluate the response rate of patients with stage IIIB or IV nonsmall cell
lung cancer to different schedules of docetaxel and gemcitabine therapy. II. Evaluate the
toxicity of this treatment in these patients. III. Describe the quality of life parameters
of patients receiving this combination therapy. IV. Determine the survival rate of these

OUTLINE: This is a randomized study. Patients are stratified by disease (stage IIIB vs stage
IV) and performance status (0 vs 1). Patients are randomized to one of two treatment arms
(Arm I now closed). Arm I: Patients receive docetaxel IV over 1 hour on day 1 followed by
gemcitabine IV over 30 minutes on days 1, 8, and 15. (closed as of 8/31/1999) Arm II:
Patients receive docetaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and
15. Arm III: Patients receive docetaxel IV on day 1 and gemcitabine IV on days 1, 8, and 15.
Patients continue treatment every 28 days for a maximum of 6 courses in the absence of
unacceptable toxicity or disease progression. Patients with either stable disease or
complete/partial response who discontinue treatment after 4-6 courses may be eligible for
NCCTG-97-24-51. Quality of life is assessed before treatment and before each course of
therapy. Patients are followed every 3 months for 1 year, then every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 19-53 patients will be accrued for this study within 6-18

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIB/IV nonsmall
cell lung cancer eligible for first line chemotherapy Measurable disease (must be outside
radiation port or proof of progressive disease) Metastatic CNS disease allowed if treated
and stable for at least 21 days prior to study

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Greater than 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at
least 10 g/dL Absolute neutrophil count at least 1500/mm3 Hepatic: Bilirubin no greater
than upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN AST no
greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular:
At least 3 months since prior myocardial infarction No uncontrolled congestive heart
failure No uncontrolled arrhythmias Other: Not pregnant or nursing Fertile patients must
use effective contraception Peripheral neuropathy less than grade 2 No history of
hypersensitivity to products containing polysorbate 80 No other significant medical
condition No meningeal carcinomatosis No weight loss of greater than 10% within past 3
months due to disease

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior
radiotherapy to pelvis, spine, or long bones and recovered No prior radiotherapy to at
least 30% of bone marrow Surgery: Greater than 4 weeks since prior major surgery Other: At
least 3 weeks since prior investigational drugs

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Edith A. Perez, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

February 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB 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 - Ann Arbor Regional Ann Arbor, Michigan  48106
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
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 - Geisinger Clinical and Medical Center Danville, Pennsylvania  17822-2001
Rapid City Regional Hospital Rapid City, South Dakota  57709