Taxoprexin Plus Carboplatin Treatment for Advanced Lung Cancer

January 22, 2018 updated by: American Regent, Inc.

A Phase III, Randomized, Study of Weekly Taxoprexin Plus Carboplatin Versus Paclitaxel Plus Carboplatin as First Line Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer

The primary objective of this trial is to compare the survival of patients with advanced non-small cell lung cancer (NSCLC) treated with weekly Taxoprexin in combination with carboplatin to those treated with paclitaxel plus carboplatin in a prospectively randomized trial. In addition, the response rate to each regimen, response duration, time to progression and time to treatment failure will be measured. Toxicity will be evaluated and compared between the two groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, multicenter, Phase III open-label study of weekly Taxoprexin® in combination with every three (3) week carboplatin compared to paclitaxel plus carboplatin every three (3) weeks, in patients with advanced non-small cell lung cancer (NSCLC) who have not received cytotoxic agents for advanced disease. Patients may have been previously treated with immunological agents. Patients will be randomized to receive Taxoprexin® at a dose of 400 mg/m2 intravenously by one (1)-hour weekly infusion, 5/6 weeks followed immediately by carboplatin AUC = 4 on weeks one (1) and four (4) as a 30 minute intravenous infusion or paclitaxel 225mg/m2 as a three (3) hour intravenous infusion followed immediately by carboplatin AUC = 6 as a 30 minute intravenous infusion, every three (3) weeks. Patients will receive Taxoprexin® and carboplatin infusions or paclitaxel and carboplatin infusions until progression of disease, intolerable toxicity, completion of six (6) treatment cycles of paclitaxel plus carboplatin or three (3) treatment cycles of Taxoprexin® plus carboplatin, refusal of continued treatment by the patient, or Investigator decision.

Study Type

Interventional

Enrollment (Actual)

519

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75201
        • US Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients must have a histologic or cytologic diagnosis of non-small cell lung cancer. At the time of study entry, patients must have locally advanced (stage IIIb) or metastatic (stage IV) disease.
  2. Patients must have at least one site of either measurable or non-measurable disease.
  3. Patients must not have received prior systemic chemotherapy for metastatic disease. Prior adjuvant systemic chemotherapy is allowed. At least six (6) months must have elapsed since any prior adjuvant systemic chemotherapy.
  4. At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other non chemotherapy anticancer systemic therapies, unless patients have progressed during or after such therapy.
  5. At least 4 weeks (28 days) since any prior radiotherapy to > 25% of the bone marrow.
  6. Patients must have ECOG performance status of 0 - 2.
  7. Patients must be at least 18 years of age.
  8. Patients must have adequate hepatic and renal function.
  9. Patients must have adequate bone marrow function.
  10. Life expectancy of at least 3 months.
  11. Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of their institution.

Exclusion Criteria:

  1. Patients who have received prior systemic chemotherapy in the adjuvant setting with a treatment-free interval of less than six (6) months.
  2. Patients who have a past or current history of neoplasms other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix and except for other cancers treated for cure and with a disease-free survival greater than 5 years.
  3. Patients with symptomatic brain metastasis(es).
  4. Women who are pregnant or nursing and men or women who are not practicing an acceptable method of birth control. Women may not breast-feed while on this study.
  5. Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
  6. Patients with current peripheral neuropathy of any etiology that is greater than grade 1.
  7. Patients with unstable or serious concurrent medical conditions.
  8. Patients with a known hypersensitivity to Cremophor.
  9. Patients with Gilbert's syndrome.
  10. Patients must not have had major surgery within the past 14 days.
  11. Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study.
  12. No known HIV disease or infection.
  13. Patients receiving ketoconazole, erythromycin, verapamil, diazepam, quinidine, or diltiazem.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm A
(Taxoprexin® + carboplatin)
Drug: Taxoprexin
6. Other events that, based upon appropriate medical judgement, may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes
Other Names:
  • Taxoprexin® (DHA-paclitaxel) Injection
ACTIVE_COMPARATOR: Arm B- Paclitaxel and carboplatin
(Paclitaxel and carboplatin)
Drug: Taxoprexin
6. Other events that, based upon appropriate medical judgement, may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes
Other Names:
  • Taxoprexin® (DHA-paclitaxel) Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Overall survival after 380 deaths
To compare the overall survival of patients with advanced NSCLC treated with either weekly Taxoprexin® in combination with carboplatin every 3 weeks or paclitaxel and carboplatin every 3 weeks. • To compare the safety and tolerability of weekly Taxoprexin® in combination with carboplatin every 3 weeks with paclitaxel and carboplatin administered every 3 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Response rate
To compare time to progression (TTP), time to treatment failure (TTF) and one-year survival in patients with advanced NSCLC treated with weekly Taxoprexin® in combination with carboplatin every 3 weeks or paclitaxel and carboplatin every 3 weeks. • To compare the objective response rates (ORR) and duration of response in patients with advanced NSCLC treated with either weekly Taxoprexin® in combination with carboplatin every 3 weeks or paclitaxel and carboplatin every 3 weeks. • Formal pharmacokinetics (PK) were to be done at selected sites for 18 patients randomized to treatment Arm A

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Regent, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2005

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

August 1, 2008

Study Registration Dates

First Submitted

October 21, 2005

First Submitted That Met QC Criteria

October 21, 2005

First Posted (ESTIMATE)

October 25, 2005

Study Record Updates

Last Update Posted (ACTUAL)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P01-04-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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