Clinical trial NCT00415363: Study of Enzastaurin Versus Placebo in the Treatment of Patients With Brain Metastases of Lung Cancer, After Whole Brain Radiation Therapy
Official title: A Double-blind, Randomized, Placebo-controlled Multicentre Phase II Study of Maintenance Enzastaurin Following Whole Brain Radiation Therapy in the Treatment of Brain Metastases From Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Small Cell Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-12-22
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multinational study to compare enzastaurin versus placebo in the treatment of patients with brain metastases of lung cancer. Approximately 108 patients will be randomly assigned to receive either enzastaurin or placebo after having completed whole brain radiotherapy.


Eligibility criteria: Inclusion Criteria:

* Having radiologically proven brain metastases of lung cancer
* Having received whole brain radiotherapy with either 30 grays in 2 weeks or 20 grays in one week. Treatment with enzastaurin must start within 14 days after the last fraction of the whole brain radiotherapy
* No other previous radiotherapy to the brain except for radiosurgery at one occasion
* Adequate organ function as measured by appropriate laboratory tests.
* Age 18 years or older.

Exclusion Criteria:

* Inability to swallow tablets or show conditions which could interfere with oral medication intake (e.g. vomiting, partial bowel obstruction).
* Inability to discontinue use of certain anti-epileptic drugs such as, carbamazepine, phenobarbital or phenytoin.
* Concurrent administration of warfarin
* Hemophilia
* Having had any systemic anti-cancer treatment within the last 2 weeks prior to enrolment.

Primary outcomes:
measure: Time to Progression of Brain Metastases
timeFrame: Baseline to measured progressive disease (up to 21.2 months)
Secondary outcomes:
measure: Time to Objective Progression of Brain Metastases
timeFrame: Baseline to measured progressive disease (up to 21.2 months)
measure: Overall Progression-free Survival (Including Both Progression of Brain and Extracranial Tumor Lesion)
timeFrame: Baseline to measured progressive disease (up to 14.4 months)
measure: Overall Survival
timeFrame: Baseline to date of death from any cause (up to 27.2 months)
measure: Overall Response (OR) to Treatment of Extra-cranial Tumor Lesions by Percentage of Participants
timeFrame: Baseline to measured progressive disease (up to 27.2 months)
measure: Best Overall Tumor Response on Brain Metastases by Percentage of Participants
timeFrame: Baseline to measured progressive disease (up to 21.2 months)
measure: Health-related Quality of Life (HRQoL) EORTC QLQ-C30 Physical Functioning
timeFrame: Baseline to 30 days after discontinuation (up to 17.6 months)
measure: HRQoL Questionnaire - EORTC QLQ-C30 Fatigue
timeFrame: Baseline to 30 days after discontinuation (up to 17.6 months)
measure: HRQoL Questionnaire - EORTC QLQ-C30 Nausea/Vomiting
timeFrame: Baseline to 30 days after discontinuation (up to 17.6 months)
measure: HRQoL Questionnaire - EORTC QLQ-C30 Diarrhea
timeFrame: Baseline to 30 days after discontinuation (up to 17.6 months)
measure: HRQoL Questionnaire - QLQ-BN20 Headache
timeFrame: Baseline to 30 days after discontinuation (up to 17.6 months)
measure: Number of Participants With Adverse Events
timeFrame: every 6 weeks (up to 27.2 months)
Other outcomes:
Locations:
city: Kobenhavn
country: Denmark
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: Bergen
country: Norway
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: Trondheim
country: Norway
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: Olsztyn
country: Poland
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: Cluj-Napoca
country: Romania
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: Gothenburg
country: Sweden
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: Umea
country: Sweden
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: