Taxoprexin Plus Carboplatin Treatment for Advanced Lung Cancer

NCT00243867 | Completed Phase 3 Results

• 1 other identifier: P01-04-20
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Advanced Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival was defined as the time from the day of randomization and ends at death of the participant. Participants were followed every 2 months, whether on or off study, for survival information. Participants alive at the time of termination of the study were considered censored.

  Up to 12 months

Secondary Outcomes (4)

• Percentage of Participants Who Achieved an Objective Complete Response or Partial Response

  Assessed every 6 weeks, up to 12 months

• Duration of Response

  Assessed every 6 weeks, up to 12 months

• Time to Progression (TTP)

  Up to 12 months

• Time to Treatment Failure (TTF)

  Baseline to stopping treatment, up to 12 months

Study Arms (2)

Taxoprexin® and carboplatin

EXPERIMENTAL

Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks Carboplatin was given at an Area Under the Curve (AUC) = 4 mg\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles.

Drug: Taxoprexin; Drug: Carboplatin

Paclitaxel and carboplatin

ACTIVE COMPARATOR

Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles.

Drug: Carboplatin; Drug: Paclitaxel

Interventions

Taxoprexin DRUG

Administered by intravenous infusion over 1 hour infusion

Also known as: Docosahexaenoic acid (DHA)-paclitaxel

Taxoprexin® and carboplatin

Carboplatin DRUG

Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate (GFR) + 25).

Also known as: Paraplatin

Paclitaxel and carboplatin; Taxoprexin® and carboplatin

Paclitaxel DRUG

Administered by intravenous infusion over 3 hour infusion

Also known as: Taxol

Paclitaxel and carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Eastern Cooperative Oncology Group (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (1)

US Oncology

Dallas, Texas, 75201, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

docosahexaenoyl-paclitaxel; Docosahexaenoic Acids; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Manager Medical Writing
• Organization: American Regent Inc.

HRathfon@americanregent.com

631-772-3555

Study Officials

• Mark A Falone, MD

  American Regent, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2005
• First Posted: October 25, 2005
• Study Start: November 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 1, 2025
• Results First Posted: August 1, 2025

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)