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Randomized Phase II Trail of Carboplatin and Gemcitabine Untreated Stage IIIB-pleural Effusion and Stage IV Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Stage IV Non-small Cell Lung Cancer, Stage IIIB-pleural Effusion

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Trial Information

Randomized Phase II Trail of Carboplatin and Gemcitabine Untreated Stage IIIB-pleural Effusion and Stage IV Lung Cancer


Subjects enrolled in the study will be placed in one of two treatment arms. All subjects
have a 50-50 chance of being placed into either treatment arm. Treatment Arm 1 will receive
chemotherapy alone, Treatment Arm 2 will receive chemotherapy with dexamethasone given
pre-treatment.


Inclusion Criteria:



- Untreated, stage IIIB with pleural effusion

- Untreated, Stage IV, non-small cell lung cancer

- Recurrent after surgery if no previous radiation therapy or chemotherapy were
administered as part of their primary treatment, except for palliative radiotherapy

- 18 years of age or older

- ECOG PS 0, 1 or 2

- At Least one target lesion according to the RECIST Criteria

- Adequate organ and marrow function

Exclusion Criteria:

- Previous cancer history unless they have had curative treatment completed at least 5
years prior to entry.

- No previous radiotherapy, chemotherapy or immunotherapy for NSCLC, except for
radiation therapy to the brain to control metastasis, bone to control pain, or lung
to relieve bronchial obstruction.

- No radiation therapy for any previous cancer to more than 25% of bone marrow.

- Uncontrolled, intercurrent illness

- Non-study corticosteroids

- Pregnant women

- Peripheral neuropathy greater than grade 1

- Uncontrolled seizures, central nervous system disorders

- Major surgery within 4 weeks of the start of study treatment

- Lack of complete recovery from major surgery.

- Glaucoma

- Lack of physical integrity of upper gastrointestinal tract, inability to swallow
tablets

- Severe acquired or hereditary immunodeficiency

- Patients with brain metastases must receive definitive treatment (radiation, surgery
or both) and be clinically and radiologically stable for 4 weeks & off
corticosteroids for at least 2 weeks prior to randomization.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine the effect of dexamethasone pre-treatment on response rates, and survival.

Outcome Time Frame:

Pre-treatment, pre-cycles 3 & 5 and 4 weeks after last treatment

Safety Issue:

No

Principal Investigator

John Rinehart

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lucille P. Markey Cancer Center at University of Kentucky

Authority:

United States: Institutional Review Board

Study ID:

CTN-0501

NCT ID:

NCT00247416

Start Date:

August 2005

Completion Date:

July 2009

Related Keywords:

  • Stage IV Non-Small Cell Lung Cancer
  • Stage IIIB-pleural Effusion
  • Untreated
  • Lung
  • Cancer
  • non-small cell
  • gemcitabine
  • gemzar
  • carboplatin
  • dexamethasone
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Pleural Effusion

Name

Location

Markey Cancer CenterLexington, Kentucky  40536
Brown Cancer CenterLouisville, Kentucky  40202
Commonwealth Cancer CenterDanville, Kentucky  40422
St. Claire Regional Medical CenterMorehead, Kentucky  40351
Montgomery Cancer CenterMt. Sterling, Kentucky  40353
Owensboro Medical HealthCare SystemOwensboro, Kentucky  42303
West Kentucky Hematology & Oncology Group, PSCPaducah, Kentucky  42003