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A Phase II Study of Taxotere and Gemcitabine for Stages III-B and IV Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

A Phase II Study of Taxotere and Gemcitabine for Stages III-B and IV Non-Small Cell Lung Cancer



- Determine the response rate of patients with recurrent stage IIIB and IV non-small cell
lung cancer treated with gemcitabine hydrochloride and docetaxel.

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

- Determine the toxic effects of this regimen in these patients.


- Determine the duration of response in patients treated with this regimen.

OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes followed by docetaxel
IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed stage IIIB or IV non-small cell lung cancer, including any
of the following types:

- Squamous cell carcinoma

- Adenocarcinoma, including bronchoalveolar cell adenocarcinoma

- Large cell anaplastic carcinoma, including giant and clear cell carcinomas

- Histologic or cytologic documentation of recurrence is required

- Measurable or evaluable disease, defined as any mass reproducibly measurable in 2
perpendicular diameters by physical examination or imaging

- The following lesions are not considered measurable or evaluable:

- Bone disease only

- Pleural or pericardial effusions

- Previously irradiated lesions, unless subsequent progression is documented

- CNS metastases allowed provided the patient undergoes at least 2 weeks of
radiotherapy prior to study entry


- Not pregnant or nursing

- Fertile patients must use effective contraception

- Negative pregnancy test

- CALGB performance status ≤ 1

- Life expectancy ≥ 3 months

- Granulocyte count > 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Creatinine ≤ 2 times normal

- Bilirubin normal

- SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase ≤
1.5 times ULN OR

- Alkaline phosphatase 4 times ULN and SGOT and/or SGPT normal

- Ejection fraction normal by ECHO or MUGA

- No history of congestive heart failure

- No psychiatric illness that would preclude study compliance

- No serious medical or psychiatric illness that would preclude giving informed consent
or limit survival to < 3 months

- No active uncontrolled bacterial, fungal, or viral infection

- No other malignancy within the past 5 years except curatively treated carcinoma in
situ of the cervix or breast, basal cell or squamous carcinoma of the skin, or other
surgically resected non-recurrent primary tumor not treated with adjuvant
radiotherapy or chemotherapy

- No pre-existing peripheral neuropathy ≥ grade 2


- At least 2 weeks since prior major surgery and recovered from acute effects

- At least 2 weeks since prior palliative radiotherapy and recovered from acute toxic

- Any persistent toxicity (e.g., alopecia or hyperpigmentation) not associated
with clinical morbidity allowed

- No prior chemotherapy

- No concurrent cranial or thoracic radiation therapy

- No concurrent cytotoxic or hormonal therapy

- Concurrent palliative radiotherapy allowed for relief of localized pain and

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

patient response rate to weekly taxotere and gemcitabine

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Antonius A. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Institutional Review Board

Study ID:




Start Date:

November 2000

Completion Date:

September 2007

Related Keywords:

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