Clinical trial · Interventional
Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer
Randomized Phase II Trail of Carboplatin and Gemcitabine Untreated Stage IIIB-pleural Effusion and Stage IV Lung Cancer
NCT00247416CI-TRIAL-00013969completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IIIB Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- 1 No Dex
- description
- No Dexamethasone
- interventionNames
- Drug: Gemcitabine
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- 2 Dex
- description
- Dexamethasone
- interventionNames
- Drug: Gemcitabine
- Drug: Dexamethasone
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Percentage of Participants With Reduction in Grade 3/4 Neutropenia
- timeFrame
- continuous throughout treatment, up to 25 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTRinehart J, Arnold S, Kloecker G, Lim A, Zaydan MA, Baeker T, Maheshwari JG, Carloss H, Slone S, Shelton B, Croley J, Kvale E, Brooks M, Leggas M. Phase II randomized trial of carboplatin and gemcitabine with or without dexamethasone pre-treatment in patients with Stage IV non-small cell lung cancer. Cancer Chemother Pharmacol. 2013 May;71(5):1375-83. doi: 10.1007/s00280-013-2111-3. Epub 2013 Mar 9. PMID 23475103