Taxoprexin Plus Carboplatin Treatment for Advanced Lung Cancer

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: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Taxoprexin; Drug: Carboplatin; Drug: Paclitaxel

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): 518
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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 Eastern Cooperative Oncology Group (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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Taxoprexin® and carboplatin; 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; Administered by intravenous infusion over 1 hour infusion; Other Names: Docosahexaenoic acid (DHA)-paclitaxel; Drug: Carboplatin; 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).; Other Names: Paraplatin
Active Comparator: Paclitaxel and carboplatin; 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; 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).; Other Names: Paraplatin; Drug: Paclitaxel; Administered by intravenous infusion over 3 hour infusion; Other Names: Taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved an Objective Complete Response or Partial Response	Antitumor response was defined as the percentage of participants who achieved an objective response (Complete Response or Partial Response), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial response was defined as a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum of LD determined by 2 consecutive observations not less than 4 weeks apart.	Assessed every 6 weeks, up to 12 months
Duration of Response	Duration of overall response was a measurement from the time measure criteria was met for confirmed complete response or partial response (whichever was first recorded) until the first date that recurrent of progressive disease was objectively documented (taking as reference for progressive disease the smallest measurement recorded since treatment started).	Assessed every 6 weeks, up to 12 months
Time to Progression (TTP)	TTP was defined as the time from randomization to documented disease progression. Progressive disease was defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as references the smallest sum LD recorded since treatment start or the appearance of 1 or more lesions.	Up to 12 months
Time to Treatment Failure (TTF)	TTF is defined as the time from randomization to the discontinuation of protocol treatment for any reason	Baseline to stopping treatment, up to 12 months

Collaborators and Investigators

• Sponsor: American Regent, Inc.
• Investigators: Study Director: Mark A Falone, MD, American Regent, Inc.

Study record dates

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 (Estimated): October 25, 2005

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Advanced Non-Small Cell Lung Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel
• Other Study ID Numbers: P01-04-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO