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A Randomized Trial of Pivanex Plus Docetaxel or Docetaxel Monotherapy in Patients With Chemotherapy Resistant Advanced Non-Small Cell Carcinoma of the Lung (NSCLC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

A Randomized Trial of Pivanex Plus Docetaxel or Docetaxel Monotherapy in Patients With Chemotherapy Resistant Advanced Non-Small Cell Carcinoma of the Lung (NSCLC)


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.


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

TTP-200-03-01

NCT ID:

NCT00073385

Start Date:

September 2003

Completion Date:

October 2004

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Lung cancer, Docetaxel, Histone deacetylase inhibitor
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Wilshire Oncology Medical GroupGlendora, California  91741
Hematology and Oncology Specialists, LLCNew Orleans, Louisiana  70115
HemOnCareBrooklyn, New York  11212
Montefiore Medical Center, Department of OncologyBronx, New York  10467
Gaston Hematology & Oncology AssociatesGastonia, North Carolina  28054