Completed

Pivanex and Docetaxel Combination Therapy for Chemotherapy Resistant Advanced Non-Small Cell Lung Cancer

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What is being tested

Data Collection

Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2003
See protocol details

Summary

Principal SponsorTitan Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2003

Actual date on which the first participant was enrolled.

This study focuses on a specific type of lung cancer known as advanced non-small cell carcinoma of the lung (NSCLC) that resists chemotherapy. The trial aims to understand if combining two drugs, Pivanex and Docetaxel, can offer better results than using Docetaxel alone. Pivanex, a histone deacetylase inhibitor, encourages tumor differentiation and/or apoptosis, and has shown promise in previous trials. Docetaxel is an approved second-line treatment for non-small cell lung cancer. The study hopes to address the challenge of chemotherapy resistance in lung cancer, potentially improving patient care and outcomes. In this open-label, randomized trial, participants with NSCLC who have undergone no more than one prior platinum-containing chemotherapy regimen are divided into two groups. One group receives both Pivanex (intravenously on Days 1-3) and Docetaxel (intravenously on Day 4), while the other group receives only Docetaxel (intravenously on Day 1). Both treatments repeat every 21 days until disease progression or treatment withdrawal. The study evaluates the survival, time to disease progression, tumor responses, and safety profile of patients in both groups to determine the effectiveness and safety of the combined therapy compared to Docetaxel alone.

Official TitleA Randomized Trial of Pivanex Plus Docetaxel or Docetaxel Monotherapy in Patients With Chemotherapy Resistant Advanced Non-Small Cell Carcinoma of the Lung (NSCLC)
NCT00073385
Principal SponsorTitan Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

225 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

11 inclusion criteria required to participate
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

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10 exclusion criteria prevent from participating
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

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Suspended

Wilshire Oncology Medical Group

La Verne, United StatesOpen Wilshire Oncology Medical Group in Google Maps
Suspended

Hematology and Oncology Specialists, LLC

New Orleans, United States
Suspended

HemOnCare

Brooklyn, United States
Suspended

Montefiore Medical Center, Department of Oncology

The Bronx, United States
Completed8 Study Centers