Clinical trial NCT00475657: Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer
Official title: Phase II Study of Pemetrexed Plus Cisplatin in the Treatment of Patients With Extensive Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-05-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Overall Response Rate
timeFrame: baseline to measured progressive disease
Secondary outcomes:
measure: Overall Survival
timeFrame: baseline to date of death from any cause
measure: Progression Free Survival
timeFrame: baseline to measured progressive disease
measure: Duration of Response
timeFrame: time of response to progressive disease
measure: Stable Disease Rate
timeFrame: baseline to measured progressive disease
Other outcomes:
Locations:
city: Ferrol
country: Spain
facility: 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.
city: La Coruña
country: Spain
facility: 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.
city: Lugo
country: Spain
facility: 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.
city: Ourense
country: Spain
facility: 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.
city: Santiago de Compostela
country: Spain
facility: 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.
city: Vigo
country: Spain
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: