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

This study has been terminated.
(low enrollment)
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier:
NCT00145418
First received: September 1, 2005
Last updated: June 19, 2014
Last verified: June 2014
  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:


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
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, see Learn About Clinical Studies.

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. 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)
Study First Received: September 1, 2005
Results First Received: July 20, 2011
Last Updated: June 19, 2014
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, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Docetaxel
Oxaliplatin
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014