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

This study has been terminated.
(low enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00145418
First Posted: September 5, 2005
Last Update Posted: June 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
  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: Intervention Model: Single Group Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • Response Rate [ Time Frame: Response is measured every 2 cycles until disease progression ]
    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 ]
    Progression is measured from each participants start of study until removal from treatment.

  • Duration of Response [ Time Frame: 0 -12 months ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Sigrun Hallmeyer, Principal Investigator, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier: NCT00145418     History of Changes
Obsolete Identifiers: NCT00393081
Other Study ID Numbers: OX-03-137 (0409)
First Submitted: September 1, 2005
First Posted: September 5, 2005
Results First Submitted: July 20, 2011
Results First Posted: January 31, 2013
Last Update Posted: June 30, 2014
Last Verified: June 2014

Keywords provided by Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.:
Non small Cell Lung Cancer Stage IIIb and IV

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Oxaliplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action