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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxaliplatin + Docetaxel
Sponsored by
Oncology Specialists, S.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Non small Cell Lung Cancer Stage IIIb and IV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Oncology Specialists, SC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

Response Rate
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
Progression is measured from each participants start of study until removal from treatment.
Duration of Response
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.
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.

Full Information

First Posted
September 1, 2005
Last Updated
June 19, 2014
Sponsor
Oncology Specialists, S.C.
Collaborators
Sanofi-Synthelabo
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1. Study Identification

Unique Protocol Identification Number
NCT00145418
Brief Title
Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
February 2005 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oncology Specialists, S.C.
Collaborators
Sanofi-Synthelabo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
Non small Cell Lung Cancer Stage IIIb and IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Oxaliplatin + Docetaxel
Other Intervention Name(s)
Eloxatin
Intervention Description
Oxaliplatin 85mg/m2 Docetaxel 30mg.m2
Primary Outcome Measure Information:
Title
Response Rate
Description
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.
Time Frame
Response is measured every 2 cycles until disease progression
Secondary Outcome Measure Information:
Title
Time to Progression
Description
Progression is measured from each participants start of study until removal from treatment.
Time Frame
<1 cycle to 6 cycles of treatment
Title
Duration of Response
Description
Duration of response is a measure of how long the participants response to therapy was maintained.
Time Frame
0 -12 months
Title
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.
Description
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.
Time Frame
day one of cycle one until participant removed from trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chadi Nabhan, MD
Organizational Affiliation
Oncology Specialists, SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncology Specialists, SC
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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