Small Cell Lung CancerPhase 2NCT00475657
Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer
A Phase 2 study testing pemetrexed and cisplatin in people with Small Cell Lung Cancer, run by Eli Lilly and Company at 6 sites in Spain.
Trial summary
The purpose of this study is to determine if cisplatin and pemetrexed are effective in the treatment of patients with Small Cell Lung Cancer, extended disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- pemetrexed and cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 6 sitesSpain
- Study dates
- Oct 2007to Apr 2008
- Phase
- Phase 2
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
- Histologic or cytologic diagnosis of Small Cell Lung Cancer (SCLC).
- Functional stage from 0 to 2 of the ECOG functional scale
- No previous systemic chemotherapy, immunotherapy or biologic therapy for SCLC.
- Previous bone marrow radiotherapy less than 25% is allowed.
- There must be at least one measurable lesion that complies with the solid tumor response evaluation criteria.
- Appropriate organic function.
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- Life expectancy estimated at 12 weeks minimum.
- Females must be surgically sterile, postmenopausal or follow approved medical contraceptive methods during the treatment period and 6 months afterwards. Males must be surgically sterile or use a contraceptive method during the treatment period and during 6 months after treatment.
- The patient must be compliant and located close to the trial area for appropriate follow-up.
- The patient or his/her legal representative must sign an informed consent document.
- Patients must be at least 18 years of age.
Who cannot join
- Having received treatment for the last 30 days with a drug that has not obtained regulatory approval.
- Having participated in a previous pemetrexed trial.
- Mixed histologic diagnosis of SCLC and NSCLC.
- Concurrent illness.
- Having an active infection.
- Severe cardiac disease.
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- Having received recently or concurrently a vaccine against yellow fever.
- Having suffered a previous malignant process other than SCLC.
- Central nervous system (CNS) metastases require concurrent corticoid therapy. Treated and stable CNS metastases are allowed.
- Clinically relevant fluid accumulation in the third space.
- Significant weight loss (greater than or equal to 10%) within 6 weeks prior to trial inclusion.
- Concurrent administration of any other anti-tumor treatment.
- Severe renal failure.
- Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDS) agents.
- Inability or unwillingness to take folic acid and vitamin B12 supplements.
- Inability to take corticoids.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
A Coruña, 15002
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ferrol, 15405
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lugo, 27004
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ourense, 15009
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Santiago de Compostela, 15706
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vigo, 36211
About this study
Official title: Phase II Study of Pemetrexed Plus Cisplatin in the Treatment of Patients With Extensive Small Cell Lung Cancer
The purpose of this study is to determine if cisplatin and pemetrexed are effective in the treatment of patients with Small Cell Lung Cancer, extended disease.
- Conditions
- Small Cell Lung Cancer
- Being tested
- pemetrexed, cisplatin
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexedDrug
Also called LY231514, Alimta
500 mg/m2, intravenous (IV), every 21 days x 6 cycles
cisplatinDrug
75 mg/m2, intravenous (IV), every 21 days x 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: pemetrexed; Drug: cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Trial terminated - results not analyzed
Measured: baseline to measured progressive disease
Secondary outcomes (4)
Overall Survival
Trial terminated - results not analyzed
Measured: baseline to date of death from any cause
Progression Free Survival
Trial terminated - results not analyzed
Measured: baseline to measured progressive disease
Duration of Response
Trial terminated - results not analyzed
Measured: time of response to progressive disease
Stable Disease Rate
Trial terminated - results not analyzed
Measured: baseline to measured progressive disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startOct 2007
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: Terminated due to lack of efficacy
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.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475657
- Sponsor's protocol ID
- 11473
- Other IDs
- H3E-XM-S113
- Status last verified
- May 2009
- First submitted
- 16 May 2007
- Last updated
- 29 May 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No