Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer - Full Text View

Purpose

It has been accepted and proven that patients with unresectable lung cancer can benefit from systemic chemotherapy. Traditional platinum-based therapy has significant side effects. Oxaliplatin and docetaxel have both shown to be effective for lung cancer. The purpose of this study is to determine if oxaliplatin combined with docetaxel has a lower toxicity profile and to determine the response rate to this study drug combination.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Oxaliplatin + Docetaxel	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 2 Study Evaluating the Safety and Efficacy of Eloxatin (Oxaliplatin) and Docetaxel as First-line Therapy of Stage IV or IIIB Unresectable Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Oxaliplatin Docetaxel

U.S. FDA Resources

Further study details as provided by Oncology Specialists, S.C.:

Primary Outcome Measures:

Response Rate [ Time Frame: Response is measured every 2 cycles until disease progression ] [ Designated as safety issue: No ]
Response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. Per RECIST 1.0 defines a complete response (CR)as the disappearance of all disease. A partial response(PR) as a minimum of a 30% decrease in the sum of the longest dimension of target lesions. Progressive disease (PR) is defined as a minimum of a 20% increase in the sum of the longest dimension of target lesions. Stable disease is defined as neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD.

Secondary Outcome Measures:

Time to Progression [ Time Frame: <1 cycle to 6 cycles of treatment ] [ Designated as safety issue: No ]
Progression is measured from each participants start of study until removal from treatment.
Duration of Response [ Time Frame: 0 -12 months ] [ Designated as safety issue: No ]
Duration of response is a measure of how long the participants response to therapy was maintained.
Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. [ Time Frame: day one of cycle one until participant removed from trial ] [ Designated as safety issue: Yes ]
Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V 3.0) and the incidence of any Grade 3 or 4 toxicities will be analyzed. Toxicity is assessed every cycle.

Enrollment:	15
Study Start Date:	February 2005
Study Completion Date:	March 2010
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer. The primary objective of the trial is to determine the response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC.	Drug: Oxaliplatin + Docetaxel Oxaliplatin 85mg/m2 Docetaxel 30mg.m2 Other Name: Eloxatin

Detailed Description:

This study is a Phase II study designed to evaluate the toxicity profile for oxaliplatin and docetaxel and to determine the response rate to this study drug combination. The primary objective of the study is response rate by RECIST criteria. The secondary objective is time to progression, duration of response, and toxicity. Patients will receive:

oxaliplatin 85mg/m2 over 2 hours on Days 1 and 15
docetaxel 30mg/m2 on Days 1 and 8

Cycles are to be repeated every 28 days for a maximum of 6 cycles.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC)
Patients must have measurable disease
Age greater than or equal to 18 years
ECOG performance score of 0, 1, or 2
Absolute neutrophil count (ANC) > 1,500
Platelets > 100,000
Serum creatinine < 1.5mg/dL
Serum total bilirubin < 1.5mg/dL
Alkaline phosphatase < 3 times the upper limit of normal
SGOT/SGPT < 3 times the upper limit of normal
Patients must be recovered from the effects of any prior surgery or RT.
Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.
Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medications.

Exclusion Criteria:

Patients with an active infection > 38.5 degrees Celsius within 3 days of the first scheduled day of protocol treatment
Patients with active central nervous system (CNS) metastasis. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 2 weeks are eligible for the trial.
History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin; cervical intra-epithelial neoplasm, or localized prostate cancer with a current prostate specific antigen (PSA) of < 1.0 mg/dL
Patients with known hypersensitivity to any of the components of oxaliplatin or docetaxel
Patients who have had prior chemotherapy for lung cancer
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment
Grade 2 peripheral neuropathy
Patients who are pregnant or lactating
Any other medical condition, including mental illness or substance abuse deemed by the investigator to be likely to interfere with the patients' ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
History of allogeneic transplant
Known HIV, hepatitis B or C (active, previously treated, or both)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145418

Locations

United States, Illinois
Oncology Specialists, SC
Park Ridge, Illinois, United States, 60068

Sponsors and Collaborators

Oncology Specialists, S.C.

Sanofi-Synthelabo

Investigators

Principal Investigator:

Chadi Nabhan, MD

Oncology Specialists, SC

More Information

No publications provided

Responsible Party:	Dr. Chadi Nabhan, Principal Investigator, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier:	NCT00145418 History of Changes
Obsolete Identifiers:	NCT00393081
Other Study ID Numbers:	OX-03-137 (0409)
Study First Received:	September 1, 2005
Results First Received:	July 20, 2011
Last Updated:	January 30, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Oncology Specialists, S.C.:

Non small Cell Lung Cancer Stage IIIb and IV

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Oxaliplatin
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013