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

NCT00145418 | Terminated Phase 2 Results

• 1 other identifier: OX-03-137 (0409)
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non small Cell Lung Cancer Stage IIIb and IV

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Time to Progression

  <1 cycle to 6 cycles of treatment

• Duration of Response

  0 -12 months

• 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.

  day one of cycle one until participant removed from trial

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

Oxaliplatin + Docetaxel DRUG

Oxaliplatin 85mg/m2 Docetaxel 30mg.m2

Also known as: Eloxatin

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oncology Specialists, S.C.: lead
• Sanofi-Synthelabo: collaborator

Study Sites (1)

Oncology Specialists, SC

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Oxaliplatin; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Limitations and Caveats

Due to lack of recruitment, the study was closed early and conclusions should not necessarily be drawn from the data presented for duration of response

Results Point of Contact

• Title: Chadi Nabhan, MD
• Organization: Oncology Specialists, S.C.

cnabhan@oncmed.net

847-268-8200

Study Officials

• Chadi Nabhan, MD

  Oncology Specialists, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: February 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: March 1, 2010
• Last Updated: June 30, 2014
• Results First Posted: January 31, 2013

Record last verified: 2014-06

Locations

US (1)