Phase 2
N=59
Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer
Stage IV Non-small Cell Lung Cancer · Stage IIIB Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00247416 ↗Enrolled (actual)
59
Serious AEs
32.2%
Results posted
Mar 2014
Primary outcome: Primary: Percentage of Participants With Reduction in Grade 3/4 Neutropenia — 40; 13 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gemcitabine (Drug); Dexamethasone (Drug); Carboplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Susanne Arnold
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Reduction in Grade 3/4 Neutropenia |
40; 13 | — |
| SECONDARY Effect of Dexamethasone Pre-treatment on Response Rate. |
8; 26 | — |
| SECONDARY Effect of Dexamethasone Pre-treatment on Overall Survival. |
291; 378 | — |
| SECONDARY Progression-free Survival |
101; 122 | — |
Summary
The purpose of this study is to find better treatment for lung cancer and to find out what effects the combined treatment of carboplatin and gemcitabine when given with or without dexamethasone have on cancer.
This study will determine if dexamethasone, when given before standard chemotherapy will increase the cancer fighting effects and reduce the side effects of chemotherapy.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00247416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.