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A Multicenter, Randomized Phase II Study of Two Schedules of Taxotere (Weekly Versus Every 3 Weeks) in Elderly or Poor Performance (ECOG PS 2), Chemotherapy-Naive Patients With Advanced Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

A Multicenter, Randomized Phase II Study of Two Schedules of Taxotere (Weekly Versus Every 3 Weeks) in Elderly or Poor Performance (ECOG PS 2), Chemotherapy-Naive Patients With Advanced Non-Small Cell Lung Cancer


OBJECTIVES:

Primary

- Compare the effects of two different schedules of docetaxel on the incidence of grade 3
and 4 toxic effects in older or poor performance chemotherapy-naïve patients with
unresectable stage IIIB or IV non-small cell lung cancer.

Secondary

- Compare the overall survival of patients treated with these regimens.

- Compare the response rate in patients treated with these regimens.

- Compare the incidence of serious adverse events in patients treated with these
regimens.

- Determine the quality of life of patients treated with these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1
of 2 treatment arms.

- Arm I: Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21
days in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Treatment
repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 2 courses during study treatment, and then at
study completion.

Patients are followed at 1 month and then every 2-3 months thereafter.

PROJECTED ACCRUAL: A total of 210-230 patients (105-115 per treatment arm) will be accrued
for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer

- Unresectable stage IIIB or IV disease

- No untreated brain or leptomeningeal metastases

- Treated patients must be neurologically stable and the adverse effects from
prior therapy must be resolved to grade 2 or less after the completion of
treatment

- No symptomatic (i.e., requiring thoracentesis) pleural effusion

- No clinically significant (i.e., grade 3 or greater) pericardial effusion

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2 (70 years of age and over) OR

- ECOG 2 (under 70 years of age)

Life expectancy

- Not specified

Hematopoietic

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

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 8.0 g/dL

Hepatic

- Bilirubin normal

- AST and ALT no greater than 2.5 times upper limit of normal (ULN) if alkaline
phosphatase is no greater than ULN OR

- Alkaline phosphatase no greater than 4 times ULN if ALT and AST are no greater than
ULN

Renal

- Not specified

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study
participation

- No grade 2 or greater peripheral neuropathy

- No prior hypersensitivity reaction to taxanes or products containing polysorbate 80

- No other active malignancy except carcinoma in situ of the cervix or basal cell skin
cancer

- No psychological, familial, sociological, or geographical condition that would
preclude study treatment or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- Recovered from prior radiotherapy (i.e., side effects resolved to grade 2 or less)

- No concurrent radiotherapy

Surgery

- More than 3 weeks since prior major surgery

Other

- More than 30 days since prior anticancer investigational drugs

- Concurrent supportive care investigational agents allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Afshin Dowlati, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000346070

NCT ID:

NCT00075374

Start Date:

October 2003

Completion Date:

Related Keywords:

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

Name

Location

Ireland Cancer CenterCleveland, Ohio  44106-5065