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

NCT ID: NCT00278460

Last Updated: 2017-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-11-30
• Study Completion Date: 2007-09-30

Brief Summary

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.

Detailed 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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

docetaxel

40 milligrams per meter squared infused over 30 minutes on day 1 and 8, repeated every 21 days

Intervention Type: DRUG

gemcitabine hydrochloride

800 milligrams per meter squared intraveneously for two consecutive weeks followe by one week of no treatment then repeated.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonius A. Miller, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Other Identifiers

CCCWFU-62199

Identifier Type: -

Identifier Source: secondary_id

AVENTIS-CCCWFU-62199

Identifier Type: -

Identifier Source: secondary_id

AG-CCCWFU-62199

Identifier Type: -

Identifier Source: secondary_id

CCCWFU-BG99-322

Identifier Type: -

Identifier Source: secondary_id

CDR0000462116

Identifier Type: -

Identifier Source: org_study_id