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Taxoprexin Plus Carboplatin Treatment for Advanced Lung Cancer

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Taxoprexin
Sponsored by
American Regent, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Advanced Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Patients must have at least one site of either measurable or non-measurable disease. 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. 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. At least 4 weeks (28 days) since any prior radiotherapy to > 25% of the bone marrow. Patients must have ECOG performance status of 0 - 2. Patients must be at least 18 years of age. Patients must have adequate hepatic and renal function. Patients must have adequate bone marrow function. Life expectancy of at least 3 months. 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: Patients who have received prior systemic chemotherapy in the adjuvant setting with a treatment-free interval of less than six (6) months. 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. Patients with symptomatic brain metastasis(es). 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. Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals). Patients with current peripheral neuropathy of any etiology that is greater than grade 1. Patients with unstable or serious concurrent medical conditions. Patients with a known hypersensitivity to Cremophor. Patients with Gilbert's syndrome. Patients must not have had major surgery within the past 14 days. Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study. No known HIV disease or infection. Patients receiving ketoconazole, erythromycin, verapamil, diazepam, quinidine, or diltiazem.

Sites / Locations

  • US Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B- Paclitaxel and carboplatin

Arm Description

(Taxoprexin® + carboplatin)

(Paclitaxel and carboplatin)

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
October 21, 2005
Last Updated
January 22, 2018
Sponsor
American Regent, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00243867
Brief Title
Taxoprexin Plus Carboplatin Treatment for Advanced Lung Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2005 (Actual)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Regent, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Advanced Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
519 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
(Taxoprexin® + carboplatin)
Arm Title
Arm B- Paclitaxel and carboplatin
Arm Type
Active Comparator
Arm Description
(Paclitaxel and carboplatin)
Intervention Type
Drug
Intervention Name(s)
Taxoprexin
Other Intervention Name(s)
Taxoprexin® (DHA-paclitaxel) Injection
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall survival after 380 deaths
Description
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 Measure Information:
Title
Response rate
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Patients must have at least one site of either measurable or non-measurable disease. 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. 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. At least 4 weeks (28 days) since any prior radiotherapy to > 25% of the bone marrow. Patients must have ECOG performance status of 0 - 2. Patients must be at least 18 years of age. Patients must have adequate hepatic and renal function. Patients must have adequate bone marrow function. Life expectancy of at least 3 months. 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: Patients who have received prior systemic chemotherapy in the adjuvant setting with a treatment-free interval of less than six (6) months. 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. Patients with symptomatic brain metastasis(es). 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. Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals). Patients with current peripheral neuropathy of any etiology that is greater than grade 1. Patients with unstable or serious concurrent medical conditions. Patients with a known hypersensitivity to Cremophor. Patients with Gilbert's syndrome. Patients must not have had major surgery within the past 14 days. Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study. No known HIV disease or infection. Patients receiving ketoconazole, erythromycin, verapamil, diazepam, quinidine, or diltiazem.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Falone, MD
Organizational Affiliation
American Regent, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
US Oncology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Taxoprexin Plus Carboplatin Treatment for Advanced Lung Cancer

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