Comparative Trial of Pivanex and Docetaxel Vs Docetaxel Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer
Completed · Phase 2
Conditions studied: Carcinoma, Non-Small-Cell Lung
In brief
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 cancer. Pivanex is an investigational agent, and docetaxel is an approved drug.
Key facts
- Study ID
- NCT00073385
- Run by
- Titan Pharmaceuticals
- People needed
- 225
- Starts
- 2003-09-01
- Expected to finish
- 2004-10-01
- Last updated by the study team
- 2005-08-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Wilshire Oncology Medical Group — La Verne, California, United States
- Hematology and Oncology Specialists, LLC — New Orleans, Louisiana, United States
- HemOnCare — Brooklyn, New York, United States
- Montefiore Medical Center, Department of Oncology — The Bronx, New York, United States
- Gaston Hematology & Oncology Associates — Gastonia, North Carolina, United States
- Rajiv Gandhi Cancer Institute & Research Center — New Delhi, India
- Regional Cancer Centre — Thiruvananthapuram, India
- University of Edinburgh, Edinburgh Cancer Centre — Edinburgh, United Kingdom
Full record on ClinicalTrials.gov
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