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Randomized Phase III Trial Comparing Targretin Capsules/Cisplatin/Vinorelbine Versus Cisplatin/Vinorelbine in Chemotherapy-Naive Patients With Advanced or Metastatic Non-Small Cell Lung Cancer


Phase 3
N/A
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

Randomized Phase III Trial Comparing Targretin Capsules/Cisplatin/Vinorelbine Versus Cisplatin/Vinorelbine in Chemotherapy-Naive Patients With Advanced or Metastatic Non-Small Cell Lung Cancer


This study evaluates the use of Targretin capsules (bexarotene) in combination with
Cisplatin and Vinorelbine for the treatment of metastatic non-small cell lung cancer in
patients who have not yet received chemotherapy for their lung cancer. Every patient
receives a platinum-containing chemotherapy every four weeks for at least four chemotherapy
cycles (approximately four months). Half of the patients are randomly assigned to receive
Targretin capsules once daily in addition to the chemotherapy. The other half is randomized
to receive a standard platinum-containing chemotherapy without Targretin capsules.

Inclusion Criteria


Patients must have:

- Pathologic (histologic or cytologic) confirmation of NSCLC

- Stage IIIB with malignant pleural effusion or Stage IV disease

- At least one measurable or evaluable NSCLC lesion that has not been previously
irradiated unless radiation therapy was more than three weeks prior to entry in the
study and the lesion has been shown to have progressed subsequent to the radiation
therapy

- ECOG performance status 0 or 1

- Adequate organ system function

- Fasting serum triglycerides that are within the age-adjusted normal range (or
normalized with appropriate intervention such as antilipid therapy prior to the
initiation of Targretin capsule therapy).

Patients must be able to complete at least four cycles of combination chemotherapy (i.e.,
approximately four months)

Patients must not have had:

- Brain metastasis

- Prior chemotherapy for NSCLC

- Prior platinum-based chemotherapy for any indication

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Mack Mabry, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Ligand Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

L1069-49

NCT ID:

NCT00050973

Start Date:

Completion Date:

March 2005

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Targretin
  • Retinoid
  • Bexarotene
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Capitol Comprehensive Cancer Care ClinicJefferson City, Missouri  65109
SUNY Downstate Medical CenterBrooklyn, New York  11203
University of FloridaGainesville, Florida  32610-0277
Brookwood Medical CenterBirmingham, Alabama  35209-6804
St. Joseph Mercy Oakland HospitalPontiac, Michigan  33308
Northwest Medical SpecialistsArlington Heights, Illinois  60004
Southern Arizona VA Healthcare SystemTucson, Arizona  85723
Arroyo Research Inc.Pasadena, California  91105
Desert Hematology-Oncology Medical Group, Inc.Rancho Mirage, California  92270
New Hope Cancer CenterHudson, Florida  34667
Veterans Affairs Medical CenterMiami, Florida  33125
Bay Area Cancer ConsultantsPalm Harbor, Florida  34684
Jayne Gurtler, M.D., APMCMetairie, Louisiana  70006
Louisiana State University Health Science CenterNew Orleans, Louisiana  70112
VA Western New York Health Care SystemBuffalo, New York  14215
Hematology-Oncology AssociatesToledo, Ohio  43623
Tariq MahmoodMIdwest City, Oklahoma  73110
University Oncology & Hematology AssociatesChattanooga, Tennessee  37404
Marshfield Medical Research FoundationMarshfield, Wisconsin  54449
Medical Associates Health CentersMenomonee Falls, Wisconsin  53051