Status:
COMPLETED
Comparative Trial of Pivanex and Docetaxel Vs Docetaxel Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
Titan Pharmaceuticals
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized study will assess the efficacy and safety of the combination of Pivanex and docetaxel compared to docetaxel alone in patients with a type of lung cancer called non-small cell lung canc...
Detailed Description
Rationale: Pivanex is a histone deacetylase inhibitor that induces tumor differentiation and/or apoptosis. Pivanex has been well tolerated in clinical trials and has shown preliminary evidence of effi...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC); Treatment with one prior platinum-based chemotherapy regimen (Eligible patients may include:
- Patients previously treated with adjuvant or neoadjuvant chemotherapy (must be completed within 6 months prior to randomization) or
- Patients who have received chemotherapy for advanced or metastatic lung cancer);
- Recurrent or progressive NSCLC (local, distant, or both) following initial chemotherapy);
- Measurable or non-measurable disease;
- Males and females, age =\> 18 years;
- Adequate renal function with creatinine =\> 1.5 mg/dl;
- Adequate liver function with alkaline phosphatase =\> 2.5 X upper limit of normal, SGOT, and SGPT =\> 1.5 X upper limit of normal; and total bilirubin =\> upper limit of normal;
- Adequate bone marrow function: platelets \> 100,000/mm3, hemoglobin =\> 9 g/dL, and absolute neutrophil count (ANC) =\> 1,500 cells/mm3;
- Able to give informed consent;
- Discontinuation of previous surgery, radiation therapy or cancer chemotherapy at least four weeks prior to randomization (six weeks if a prior nitrosourea or mitomycin C), with recovery from treatment-associated toxicity;
- A predicted life expectancy of at least 12 weeks; and
- ECOG performance status of 0, 1, or 2.
Exclusion
- Receipt of more than one chemotherapy regimen for NSCLC;
- A second malignancy within the last 5 years other than curatively treated carcinoma-in-situ or non-melanoma skin cancer;
- Pregnant or lactating females (Females of childbearing potential must have a negative pregnancy test and all male and female patients of reproductive potential must agree to use adequate birth control);
- Known HIV-positive patients;
- Acute medical problems, such as ischemic heart or lung disease or uncontrolled systemic infection;
- Patients with any underlying medical conditions or circumstance, which would contraindicate therapy with study treatment, affect compliance or impair evaluation of study endpoints;
- Patients receiving investigational agents within 30 days of the screening visit;
- Known allergy to reagents in the study;
- Prior docetaxel therapy;
- Symptomatic or untreated brain metastases (Patients with brain metastases are eligible if they are clinically and neurologically stable for \> 4 weeks since therapy (radiation therapy, radiosurgery/gamma knife; surgical resection) as determined by the investigator and either off corticosteroids or on a stable dose of corticosteroids).
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2004
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT00073385
Start Date
September 1 2003
End Date
October 1 2004
Last Update
August 30 2005
Active Locations (8)
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1
Wilshire Oncology Medical Group
La Verne, California, United States, 91750
2
Hematology and Oncology Specialists, LLC
New Orleans, Louisiana, United States, 70115
3
HemOnCare
Brooklyn, New York, United States, 11235
4
Montefiore Medical Center, Department of Oncology
The Bronx, New York, United States, 10467