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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

Phase 3
18 Years
Not Enrolling
Non-small Cell Lung Cancer

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Trial Information

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

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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival after 380 deaths

Principal Investigator

Robert Bellet, MD

Investigator Role:

Study Director

Investigator Affiliation:

Luitpold Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

November 2005

Completion Date:

April 2008

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Advanced Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



US OncologyHouston, Texas  77060