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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome 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.

Outcome Time Frame:

Response is measured every 2 cycles until disease progression

Safety Issue:

No

Principal Investigator

Chadi Nabhan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oncology Specialists, SC

Authority:

United States: Institutional Review Board

Study ID:

OX-03-137 (0409)

NCT ID:

NCT00145418

Start Date:

February 2005

Completion Date:

March 2010

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Non small Cell Lung Cancer Stage IIIb and IV
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Oncology Specialists, SCPark Ridge, Illinois  60068