Gemcitabine and Docetaxel in Treating Patients With Recurrent Stage III or Stage IV Non-Small Cell Lung Cancer

Wake Forest University (WFU)

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Treatments

Drug: docetaxel

Drug: gemcitabine hydrochloride

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00278460

CDR0000462116

CCCWFU-62199

AVENTIS-CCCWFU-62199

AG-CCCWFU-62199

CCCWFU-BG99-322

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent stage III or stage IV non-small cell lung cancer.

Full description

OBJECTIVES:

Primary

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

Secondary

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.

Enrollment

49 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

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 effects
- 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 obstruction