NCT00073385

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_2

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2003

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

August 30, 2005

Status Verified

August 1, 2005

First QC Date

November 19, 2003

Last Update Submit

August 26, 2005

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Lung cancer, Docetaxel, Histone deacetylase inhibitor

Interventions

PivanexDRUG
DocetaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Wilshire Oncology Medical Group

La Verne, California, 91750, United States

Location

Hematology and Oncology Specialists, LLC

New Orleans, Louisiana, 70115, United States

Location

HemOnCare

Brooklyn, New York, 11235, United States

Location

Montefiore Medical Center, Department of Oncology

The Bronx, New York, 10467, United States

Location

Gaston Hematology & Oncology Associates

Gastonia, North Carolina, 28054, United States

Location

Rajiv Gandhi Cancer Institute & Research Center

New Delhi, 110 085, India

Location

Regional Cancer Centre

Thiruvananthapuram, 695 011, India

Location

University of Edinburgh, Edinburgh Cancer Centre

Edinburgh, EH4 2XU, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

pivalyloxymethyl butyrateDocetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 19, 2003

First Posted

November 21, 2003

Study Start

September 1, 2003

Study Completion

October 1, 2004

Last Updated

August 30, 2005

Record last verified: 2005-08

Locations

US(5)IN(2)GB(1)