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Comparative Trial of Pivanex and Docetaxel Vs Docetaxel Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00073385
Recruitment Status : Completed
First Posted : November 21, 2003
Last Update Posted : August 30, 2005
Sponsor:
Information provided by:
Titan Pharmaceuticals

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 cancer. Pivanex is an investigational agent, and docetaxel is an approved drug.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Pivanex Drug: Docetaxel Phase 2

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 efficacy in patients with non-small cell lung cancer. Docetaxel is an approved drug for second-line treatment of non-small cell lung cancer. Preclinical studies indicate that the combination of Pivanex and docetaxel is synergistic.

Purpose: This open-label randomized trial will evaluate whether combination therapy with Pivanex and docetaxel provides clinical benefit over docetaxel alone in patients with chemotherapy resistant non-small cell lung cancer.

Objectives:

  • Compare the survival of patients with non-small cell lung cancer treated with combination therapy with Pivanex and docetaxel vs. docetaxel alone
  • Compare the time to disease progression, tumor responses, and safety profile of patients with non-small cell lung cancer treated with combination therapy with Pivanex and docetaxel vs. docetaxel alone

Outline: This is a randomized, open-label, multicenter study in patients with non-small cell lung cancer who have previously been treated with no more than one prior platinum containing chemotherapy regimen. Patients are stratified by ECOG performance status (0-1 vs. 2), response to prior platinum based chemotherapy (progression vs. CR/PR/SD) and prior taxane therapy (yes vs. no). Patients are randomized to 1 of 2 treatment arms.

  • Arm A: Patients receive the combination of Pivanex intravenously on Days 1-3 and docetaxel intravenously on Day 4. Treatment repeats every 21 days until disease progression or treatment withdrawal.
  • Arm B: Patients receive docetaxel intravenously on Day 1. Treatment repeats every 21 days until disease progression or treatment withdrawal.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Pivanex Plus Docetaxel or Docetaxel Monotherapy in Patients With Chemotherapy Resistant Advanced Non-Small Cell Carcinoma of the Lung (NSCLC)
Study Start Date : September 2003
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC); Treatment with one prior platinum-based chemotherapy regimen (Eligible patients may include:

    1. Patients previously treated with adjuvant or neoadjuvant chemotherapy (must be completed within 6 months prior to randomization) or
    2. 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 Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073385


Locations
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United States, California
Wilshire Oncology Medical Group
La Verne, California, United States, 91750
United States, Louisiana
Hematology and Oncology Specialists, LLC
New Orleans, Louisiana, United States, 70115
United States, New York
Montefiore Medical Center, Department of Oncology
Bronx, New York, United States, 10467
HemOnCare
Brooklyn, New York, United States, 11235
United States, North Carolina
Gaston Hematology & Oncology Associates
Gastonia, North Carolina, United States, 28054
India
Rajiv Gandhi Cancer Institute & Research Center
New Delhi, India, 110 085
Regional Cancer Centre
Thiruvananthapuram, India, 695 011
United Kingdom
University of Edinburgh, Edinburgh Cancer Centre
Edinburgh, United Kingdom, EH4 2XU
Sponsors and Collaborators
Titan Pharmaceuticals

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ClinicalTrials.gov Identifier: NCT00073385     History of Changes
Other Study ID Numbers: TTP-200-03-01
NSCLC Clincal Trial
First Posted: November 21, 2003    Key Record Dates
Last Update Posted: August 30, 2005
Last Verified: August 2005

Keywords provided by Titan Pharmaceuticals:
Lung cancer, Docetaxel, Histone deacetylase inhibitor

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Histone Deacetylase Inhibitors
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors