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Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer


OBJECTIVES:

Primary

- Determine the response rate in patients with inoperable stage IIIB or IV non-small cell
lung cancer treated with gemcitabine and docetaxel.

Secondary

- Determine the progression-free and overall survival of patients treated with this
regimen.

- Determine the tolerance profile of this regimen in these patients.

- Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive docetaxel IV over 1 hour and gemcitabine IV over 2 hours on day 1.
Treatment repeats every 15 days for up to 12 courses in the absence of disease progression
or unacceptable toxicity.

Quality of life is assessed at baseline, after courses 6 and 12, and then every 3 months
thereafter.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer of 1 of the
following histologic subtypes:

- Epidermoid carcinoma

- Large cell carcinoma

- Adenocarcinoma

- Stage IIIB (T4, any N, M0 OR any T, N3, M0) OR Stage IV disease

- Inoperable disease

- Measurable disease

- At least 1 unidimensionally measurable lesion at least 20 mm by conventional
techniques OR at least 10 mm by spiral CT scan

- No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 to 75

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

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

- Absolute neutrophil count at least 2,000/mm^3

- Hemoglobin at least 10 g/dL

Hepatic

- Bilirubin no greater than normal

- Transaminases no greater than 1.5 times normal

- Alkaline phosphatase no greater than 2.5 times normal

Renal

- Creatinine no greater than 2.3 mg/dL

Cardiovascular

- No uncontrolled cardiac insufficiency

Other

- Not pregnant or nursing

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

- No uncontrolled infection

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

- No grade 3 or 4 brain disorder

- No intolerance to polysorbate 80 or cortisones

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy, including taxanes or gemcitabine

- No other concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy to more than 20% of the bone marrow

- No prior radiotherapy for lung cancer

- At least 4 weeks since other prior radiotherapy and recovered

Surgery

- No prior surgery for lung cancer

Other

- More than 30 days since prior clinical trial participation

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

Philippe Terrioux, MD

Investigator Affiliation:

Clinique de Docteur Terrioux

Authority:

United States: Federal Government

Study ID:

CDR0000346806

NCT ID:

NCT00075517

Start Date:

September 2003

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • large cell lung cancer
  • squamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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