Clinical trial NCT00535015: Safety and Efficacy Study of Betamarc to Treat Loss of Weight and Appetite in Non-Small Cell Lung Cancer
Official title: A Randomized, Double-Blind, Pilot Study Comparing the Safety and Efficacy of Betamarc Plus Chemotherapy to Chemotherapy Alone in the Prevention and Treatment of CACS in Patients With Advanced NSCLC
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Anorexia
Cachexia
Weight Loss
Carcinoma, Non-Small-Cell Lung
Lead sponsor: Anaborex
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 70
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: The purpose of this study is to determine whether Betamarc is effective in improving the appetite and reversing weight loss in patients with advanced Non-Small Cell Lung Cancer.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed Stage IIIB or IV non-resectable NSCLC. Recurrent disease after resection for earlier stage disease is acceptable as long as patients are at least 6 months from surgery.
* Treatment plan includes a platinum-based doublet chemotherapy.
* ECOG 0, 1 or 2.
* Self-reported loss of body weight or anorexia.
* Serum C-reactive protein ≥5 mg/L.
* Life expectancy of at least 6 months.
* Adequate bone marrow, liver and renal function.
* Normal serum potassium.
* Ability to comply with the study requirements and give written informed consent.

Exclusion Criteria:

* Known physical or functional obstruction of the gastrointestinal tract, malabsorption, intractable vomiting, uncontrollable diarrhea, concurrently receiving tube feeding or parenteral nutrition, or unable to swallow investigational drug product.
* Concomitant therapy with an appetite stimulant.
* History of poorly controlled hypertension or congestive heart failure.
* Any implanted devices that could interfere with DXA scanning.
* Prolongation of QT interval.
* History of additional risk factors for torsades de pointe.
* Concomitant therapy with beta-adrenergic receptor antagonists (beta-blockers) or ergot derivatives.
* Females who are breast feeding, pregnant or of child-bearing potential who are not using adequate birth control.
* Any second malignancy which might confound the interpretation of safety or efficacy assessments.
* Any condition which increases the patient's risk for participating in the study.

Primary outcomes:
measure: Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate
timeFrame: 25 weeks
Secondary outcomes:
measure: Adverse events, ECG, vital signs, clinical laboratory parameters and physical examination
timeFrame: 25 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Elizabeth Hospital
city: Hong Kong
country: China
facility: Tuen Mun Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Cathay General Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Muncipal Wan Fang Hospital
Study officials:
affiliation: Cathay General Hospital
name: Yung-chuan Sung
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Medical University Muncipal Wan Fang Hospital
name: Hsing-jin Eugene Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University Hospital
name: Te-chun Hsia
role: PRINCIPAL_INVESTIGATOR
affiliation: Taichung Veterans General Hospital
name: Gee-chen Chang
role: PRINCIPAL_INVESTIGATOR
affiliation: Tzu Chi General Hospital Taipei Branch
name: Yao-kuang Wu
role: PRINCIPAL_INVESTIGATOR
affiliation: Tuen Mun Hospital
name: Kwok-keung Yuen
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Mary Hospital, Hong Kong
name: Daniel Chua
role: PRINCIPAL_INVESTIGATOR
affiliation: The Queen Elizabeth Hospital
name: Chung-kong Kwan
role: PRINCIPAL_INVESTIGATOR
affiliation: Prince of Wales Hospital
name: Kwok-chi Lam
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Dae-ho Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hosptial
name: Jong-seok Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Vincent's Hospital, Korea
name: Hoon-kyo Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea, St. Mary's Hospital
name: Jin-hyoung Kang
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaya
name: Anita Zarina binti Bustam
role: PRINCIPAL_INVESTIGATOR
affiliation: Penang Hospital, Malaysia
name: Abdul Razak bin Abdul Muttalif
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universiti Sains Malaysia
name: Biswa Mohan Biswal
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cheng-Kung University Hospital
name: Wu-chou Su
role: PRINCIPAL_INVESTIGATOR
affiliation: Chunghua Christian Hospital
name: Ming-lin Ho
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung Shan Medical University
name: Chang-yao Tsao
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital, Chiayi
name: Cheng-ta Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: Chi Mei Medical Center Liou-Ying Campus
name: Wen-Tsung Huang
role: PRINCIPAL_INVESTIGATOR
affiliation: Dharmais Cancer Hospital
name: Edy Suratman
role: PRINCIPAL_INVESTIGATOR
affiliation: Persahabatan Hospital
name: Elisna Syahruddin
role: PRINCIPAL_INVESTIGATOR
affiliation: Gatot Subroto Central Army Hospital
name: Alexander Ginting
role: PRINCIPAL_INVESTIGATOR
References: