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

NCT00278460 | Completed Phase 2

• 5 other identifiers: CDR0000462116CCCWFU-62199AVENTIS-CCCWFU-62199AG-CCCWFU-62199CCCWFU-BG99-322
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• patient response rate to weekly taxotere and gemcitabine

  6 weeks

Secondary Outcomes (1)

• Evaluate toxicity of weekly Taxotere and Gemcitabine

  6 weeks

Interventions

docetaxel DRUG

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

gemcitabine hydrochloride DRUG

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Docetaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Antonius A. Miller, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2006
• First Posted: January 18, 2006
• Study Start: November 1, 2000
• Primary Completion: February 1, 2006
• Study Completion: September 1, 2007
• Last Updated: January 19, 2017

Record last verified: 2012-07