Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

NCT00305786 | Completed Phase 2 DMC

• 3 other identifiers: 20043597SCCC-2004078WIRB-20050485
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, 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 oxaliplatin works as second-line therapy in treating patients with stage III or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Response rate as measured by RECIST criteria

  At study completion

Secondary Outcomes (1)

• Toxicity as monitored by DSMC

  At study completion

Interventions

gemcitabine hydrochloride DRUG

oxaliplatin DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically proven stage IIIB or IV non-small cell lung cancer (NSCLC) * Failed first-line chemotherapy * Must have received ≥ 1, but no more than 2, prior chemotherapy regimens for stage IIIB or IV NSCLC * Prior radiotherapy or surgery for earlier stage disease allowed, provided target lesions chosen for response assessment have not have been irradiated * At least 1 unidimensionally measurable lesion with diameter ≥ 20 mm by conventional methods OR ≥ 10 mm by spiral CT scan * If a single lesion is identified as the target lesion, histological or cytological confirmation of this lesion is required * No symptomatic brain metastases * Clinically stable brain metastases on a stable dose of (or no longer requiring) dexamethasone allowed PATIENT CHARACTERISTICS: * ECOG performance status 0 or 1 * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin ≤ 1.5 mg/dL * AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement) * Creatinine ≤ 1.5 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after completion of study treatment * No history of an acute cardiac or CNS event within the past 6 months, including any of the following: * Unstable angina * Myocardial infarction * Clinically relevant arrhythmia * Stroke * No current clinical evidence of congestive heart failure or unstable coronary artery disease * No peripheral neuropathy \> grade 1 * No history of hypersensitivity to study drugs * No serious uncontrolled medical or psychiatric illness, including any of the following: * Serious infection * Interstitial pneumonia * Extensive and symptomatic fibrosis of the lung * No other malignancy within the past year, except for squamous cell or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior surgery * At least 4 weeks since prior cranial radiation for brain metastases * More than 4 weeks since prior participation in another investigational drug study * No concurrent immunotherapy

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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (2)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Caio Max S. Rocha Lima, MD

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 22, 2006
• Study Start: August 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: May 1, 2010
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

US (2)