Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00145418
Recruitment Status : Terminated (low enrollment)
First Posted : September 5, 2005
Results First Posted : January 31, 2013
Last Update Posted : June 30, 2014
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.

Tracking Information
First Submitted Date  ICMJE September 1, 2005
First Posted Date  ICMJE September 5, 2005
Results First Submitted Date July 20, 2011
Results First Posted Date January 31, 2013
Last Update Posted Date June 30, 2014
Study Start Date  ICMJE February 2005
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
Response Rate
Change History Complete list of historical versions of study NCT00145418 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
  • Time to Progression
  • Duration of Response
  • Toxicity
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer
Official Title  ICMJE 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
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE Drug: Oxaliplatin + Docetaxel
Oxaliplatin 85mg/m2 Docetaxel 30mg.m2
Other Name: Eloxatin
Study Arms 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.
Intervention: Drug: Oxaliplatin + Docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 3, 2008)
15
Original Enrollment  ICMJE
 (submitted: September 2, 2005)
48
Actual Study Completion Date March 2010
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00145418
Other Study ID Numbers  ICMJE OX-03-137 (0409)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
Study Sponsor  ICMJE Oncology Specialists, S.C.
Collaborators  ICMJE Sanofi-Synthelabo
Investigators  ICMJE
Principal Investigator: Chadi Nabhan, MD Oncology Specialists, SC
PRS Account Oncology Specialists, S.C.
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP