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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00145418
• Other study ID #: OX-03-137 (0409)
• Status: Terminated
• Phase: Phase 2
• First received: September 1, 2005
• Last updated: June 19, 2014
• Start date: February 2005
• Est. completion date: March 2010

Study information

• Verified date: June 2014
• Source: Oncology Specialists, S.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00393081

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: March 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Oxaliplatin + Docetaxel
Oxaliplatin 85mg/m2 Docetaxel 30mg.m2

Locations

Country	Name	City	State
United States	Oncology Specialists, SC	Park Ridge	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Oncology Specialists, S.C.	Sanofi-Synthelabo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Response is measured every 2 cycles until disease progression	No
Secondary	Time to Progression	Progression is measured from each participants start of study until removal from treatment.	<1 cycle to 6 cycles of treatment	No
Secondary	Duration of Response	Duration of response is a measure of how long the participants response to therapy was maintained.	0 -12 months	No
Secondary	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.	day one of cycle one until participant removed from trial	Yes