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Non-Small Cell Lung CancerPhase 3NCT00243867

Taxoprexin Plus Carboplatin Treatment for Advanced Lung Cancer

A Phase 3 study testing Taxoprexin, Carboplatin and Paclitaxel in people with Non-Small Cell Lung Cancer, run by American Regent, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Taxoprexin, Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
518 participants
Where
1 siteUnited States
Study dates
Nov 2005to Aug 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • US Oncology

    Dallas, Texas, 75201

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Taxoprexin, Carboplatin, Paclitaxel
Keywords
Advanced Non-Small Cell Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TaxoprexinDrug

    Also called Docosahexaenoic acid (DHA)-paclitaxel

    Administered by intravenous infusion over 1 hour infusion

  • CarboplatinDrug

    Also called Paraplatin

    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).

  • PaclitaxelDrug

    Also called Taxol

    Administered by intravenous infusion over 3 hour infusion

Study groups in NCT00243867
Study groupRoleWhat they receive
Taxoprexin® and carboplatinExperimentalTaxoprexin® 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.
Receives: Drug: Taxoprexin; Drug: Carboplatin
Paclitaxel and carboplatinActive comparatorPaclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles.
Receives: Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 12 months

Secondary outcomes (4)

  1. 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.

    Measured: Assessed every 6 weeks, up to 12 months

  2. 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).

    Measured: Assessed every 6 weeks, up to 12 months

  3. 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.

    Measured: Up to 12 months

  4. Time to Treatment Failure (TTF)

    TTF is defined as the time from randomization to the discontinuation of protocol treatment for any reason

    Measured: Baseline to stopping treatment, up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionAug 2008
  4. Study completionAug 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
518 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00243867
Sponsor's protocol ID
P01-04-20
Status last verified
Jan 2018
First submitted
21 Oct 2005
Last updated
1 Aug 2025
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Taxoprexin, Carboplatin and Paclitaxel in people with Non-Small Cell Lung Cancer, run by American Regent, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00243867.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.

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