Stage IV Non-small Cell Lung CancerPhase 2NCT00247416
Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer
A Phase 2 study testing Gemcitabine, Dexamethasone and Carboplatin in people with Stage IV Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, run by Susanne Arnold at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
- What is being tested?
- Gemcitabine, Dexamethasone and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2005to Jul 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Commonwealth Cancer Center
Danville, Kentucky, 40422
Markey Cancer Center
Lexington, Kentucky, 40536
Brown Cancer Center
Louisville, Kentucky, 40202
St. Claire Regional Medical Center
Morehead, Kentucky, 40351
Montgomery Cancer Center
Mount Sterling, Kentucky, 40353
Owensboro Medical HealthCare System
Owensboro, Kentucky, 42303
West Kentucky Hematology & Oncology Group, PSC
Paducah, Kentucky, 42003
About this study
Official title: Randomized Phase II Trail of Carboplatin and Gemcitabine Untreated Stage IIIB-pleural Effusion and Stage IV Lung Cancer
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.
Read the detailed description
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.
- Being tested
- Gemcitabine, Dexamethasone, Carboplatin
- Keywords
- Untreated, Lung, Cancer, non-small cell, gemcitabine, gemzar, carboplatin, dexamethasone
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.
DexamethasoneDrug
16 mg bid for 4 days prior to each chemotherapy start.
CarboplatinDrug
AUC 6.0 intravenously over 30 minutes on day 5.
| Study group | Role | What they receive |
|---|---|---|
| 1 No Dex | Other | No Dexamethasone Receives: Drug: Gemcitabine; Drug: Carboplatin |
| 2 Dex | Experimental | Dexamethasone Receives: Drug: Gemcitabine; Drug: Dexamethasone; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Reduction in Grade 3/4 Neutropenia
Reduction grade 3/4 neutropenia
Measured: continuous throughout treatment, up to 25 weeks
Secondary outcomes (3)
Effect of Dexamethasone Pre-treatment on Response Rate.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment
Effect of Dexamethasone Pre-treatment on Overall Survival.
Overall survival
Measured: Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days
Progression-free Survival
progression-free survival
Measured: Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startAug 2005
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IV Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susanne Arnold
- Sponsor type
- University, hospital or other
- Collaborators
- Kentucky Lung Cancer Research Program
- Responsible party
- Sponsor-investigator, Susanne Arnold, University of Kentucky
- Investigators
- John Rinehart, Principal investigator, Lucille P. Markey Cancer Center at University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247416
- Sponsor's protocol ID
- CTN-0501
- Status last verified
- Jan 2014
- First submitted
- 28 Oct 2005
- Last updated
- 7 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rinehart 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.
PubMed 23475103
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trail of Carboplatin and Gemcitabine Untreated Stage IIIB-pleural Effusion and Stage IV Lung Cancer
- ClinicalTrials.gov ID
- NCT00247416
- Acronym / sponsor ID
- CTN-0501
- Keywords
- Untreated, Lung, Cancer, non-small cell, gemcitabine, gemzar, carboplatin, dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Susanne ArnoldUniversity, hospital or other
- Collaborators
- Kentucky Lung Cancer Research Program
- Study start
- Aug 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 1 Nov 2005 (estimated)
- Results
- Posted 7 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 No Dex | Other | Drug: Gemcitabine, Drug: CarboplatinNo Dexamethasone |
| 2 Dex | Experimental | Drug: Gemcitabine, Drug: Dexamethasone, Drug: CarboplatinDexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcitabineAlso: GemzarGemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12. | Drug | 1 No Dex, 2 Dex |
| Dexamethasone16 mg bid for 4 days prior to each chemotherapy start. | Drug | 2 Dex |
| CarboplatinAUC 6.0 intravenously over 30 minutes on day 5. | Drug | 1 No Dex, 2 Dex |
Primary outcome
Percentage of Participants With Reduction in Grade 3/4 Neutropenia
Time frame: continuous throughout treatment, up to 25 weeks
Reduction grade 3/4 neutropenia
3 secondary outcomes
Effect of Dexamethasone Pre-treatment on Response Rate.
Time frame: Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment
Effect of Dexamethasone Pre-treatment on Overall Survival.
Time frame: Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days
Progression-free Survival
Time frame: Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23475103Rinehart 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Rinehart principal investigator
Lucille P. Markey Cancer Center at University of Kentucky
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Dexamethasone and Carboplatin in people with Stage IV Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, run by Susanne Arnold at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Reduction in Grade 3/4 Neutropenia (time frame: continuous throughout treatment, up to 25 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00247416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2014.