Randomized Study With New Combination Chemotherapies in Advanced Non-Small Cell Lung Cancer


Phase 3
18 Years
75 Years
Not Enrolling
Both
Lung Cancer

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Trial Information

Randomized Study With New Combination Chemotherapies in Advanced Non-Small Cell Lung Cancer


OBJECTIVES: I. Compare the overall survival between paclitaxel/cisplatin (arm I),
gemcitabine/cisplatin (arm II), and paclitaxel/gemcitabine (arm III) in patients with
advanced non-small cell lung cancer. II. Determine the response rate, duration of response,
progression-free survival, toxicity, and quality of life of these patients randomized in
these three treatment arms.

OUTLINE: This is randomized, multicenter study. Patients are stratified according to
performance status (0-1 vs 2) and stage of disease (locally advanced vs metastatic).
Patients are randomized to receive paclitaxel IV over 3 hours on day 1 followed by cisplatin
IV on day 1 every 3 weeks (arm I), gemcitabine IV over 30-60 minutes on days 1 and 8 and
cisplatin IV on day 1 every 3 weeks (arm II), or paclitaxel IV over 3 hours on day 1
followed by gemcitabine IV over 30-60 minutes on days 1 and 8 every 3 weeks (arm III).
Patients receive at least 2 courses of treatment. In the absence of unacceptable toxicity
and disease progression, patients may receive up to 6 courses of treatment. Quality of life
is assessed before, during, and at the end of treatment, then every 6 weeks until disease
progression, and then every 3 months until death. Patients are followed every 6 weeks until
disease progression, then every 3 months until death.

PROJECTED ACCRUAL: A total of 450 patients (150 patients per arm) will be accrued into this
study over 36 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed advanced non-small cell lung cancer that
is progressive within 2 months prior to study entry Stage IIIB due to malignant pleural
effusion or supraclavicular lymph node involvement only Stage IV At least 1
bidimensionally or unidimensionally measurable target lesion Brain metastases or
leptomeningeal disease that have been treated with radiotherapy, is stable without
medications (e.g., steroids), and asymptomatic are allowed

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at
least 100,000/mm3 Prothrombin time less than 1.5 times normal Hepatic: Bilirubin no
greater than 1.25 times upper limit of normal (ULN) (no greater than 2.5 times ULN if due
to liver metastases) AST or ALT less than 3 times ULN (no greater than 5 times ULN if due
to liver metastases) Renal: Creatinine clearance at least 60 mL/min Cardiovascular: No
uncontrolled cardiac disease, sign of cardiac failure, or rhythm disturbances requiring
medication No myocardial infarction in the past 3 months Neurological: No preexisting
motor or sensory neurotoxicity of grade 2 or greater Other: No active uncontrolled
infection Not a poor medical risk due to nonmalignant disease No secondary primary
malignancy in the past 5 years (excluding melanoma, breast cancer, and hypernephroma)
except carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the
skin No psychological condition that might hamper compliance in this study Not pregnant
Effective contraception required of all fertile patients during and for 3 months after
study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No
concurrent colony stimulating factor except for secondary prophylaxis in case of infection
and severe neutropenia No concurrent immunotherapy Chemotherapy: No prior chemotherapy for
advanced disease, including intracavitary chemotherapy At least 1 year since prior
neoadjuvant or adjuvant chemotherapy No concurrent chemotherapy Endocrine therapy: See
Disease Characteristics No concurrent hormonal agents (except corticosteroids for
antiemetic prophylaxis) Radiotherapy: Prior radiotherapy should not include all target
lesions for evaluation At least 4 weeks since prior radiotherapy Concurrent palliative
radiotherapy allowed if indicator lesion is outside of radiation field Surgery: Not
specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Egbert F. Smit, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Free University Medical Center

Authority:

United States: Federal Government

Study ID:

EORTC-08975

NCT ID:

NCT00003589

Start Date:

August 1998

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent 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

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