Clinical trial NCT00332280: Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo
Official title: A Prospective, Randomised, Multicenter Phase II/III Clinical Trial to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT Versus Placebo
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Gastrointestinal Cancer
Prostate Cancer
Genital Neoplasms, Female
Keywords: solid tumors
clinical benefit
quality of life
esophageal cancer
colon cancer
pancreatic cancer
gastric cancer
liver cancer
gall bladder cancer
prostate cancer
gynecological cancer
lung cancer
Tumors of GI tract, prostate and gynaecological
Lead sponsor: Auron Healthcare GmbH
Sponsor class: INDUSTRY
First posted: 2006-06-01
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced disease.

The primary evaluation criterion is clinical benefit response.

Detailed description: The study will include patients with a variety of solid tumors (i.e. esophageal, colon, pancreatic, bronchial, gastric, hepatocellular, gall bladder, prostate and gynaecological carcinomas.)

The clinical benefit response - CBR, is an end point that provides a clinical measure for symptom improvement in patients. The key evaluation parameters for CBR will be assessment of pain, the ability to perform daily activities and weight change.

Eligibility criteria: Inclusion Criteria:

* Cancer confirmed by histology or cytology
* At least one measurable lesion
* Advanced disease refractory to standard therapy or for which no standard therapy exists
* Life expectancy at least 3 months

Exclusion Criteria:

* Known secondary neoplasia or central nervous system (CNS) metastases, acute or chronic leukemia, lymphoma or multiple myeloma
* Body weight below 45 kg
* Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective birth control methods
* Concurrent severe or uncontrolled medical disease
* Acute or chronic liver disease
* Confirmed diagnosis of HIV
* Insulin dependent diabetes mellitus/abnormal glucose tolerance test (GTT)/latent diabetes mellitus type I or II
* Chemotherapy or radiotherapy less than 4 weeks prior to entry
* Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery)
* Participation in a clinical trial less than 30 days prior to entry into this study

Primary outcomes:
measure: Improvement in clinical benefit response
timeFrame: Jan 2010
Secondary outcomes:
measure: Progression free survival
timeFrame: Jan 2010
measure: Overall survival
timeFrame: Jan 2010
measure: Overall response rate
timeFrame: 2010
measure: Duration of response
timeFrame: January 2010
measure: Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30])
timeFrame: Jan 2010
measure: Safety and tolerability
timeFrame: Jan 2010
Other outcomes:
Locations:
city: Sarajevo
country: Bosnia and Herzegovina
facility: Klinicki Centar Univerziteta Sarajevo - Klinika za gastroenterohepatologiju
city: Freiburg im Breisgau
country: Germany
facility: Clinic SanaFontis
Study officials:
affiliation: Clinic SanaFontis
name: Joachim Drevs, PD Dr. Med
role: PRINCIPAL_INVESTIGATOR
References: