Clinical trial NCT00405873: Study to Evaluate Tumour Response in Cancer Patients With Advanced Hepatocellular Carcinoma (Liver Cancer) With AMT2003
Official title: A Prospective, Open, Single-arm, Multicenter Phase II Clinical Trial to Evaluate the Tumour Response and Safety in Patients With Advanced Primary Hepatocellular Carcinoma Treated With AMT2003
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Primary hepatocellular carcinoma
Liver cancer
Tumour response
Quality of life
Lead sponsor: Auron Healthcare GmbH
Sponsor class: INDUSTRY
First posted: 2006-11-30
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
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 primary hepatocellular carcinoma

The primary endpoint is best overall response rate within 20 weeks after registration

Detailed description: The study will include patients with advanced primary hepatocellular carcinoma refractory to standard therapy or for which no effective standard therapy exists.

The best overall response rate is the best response recorded from the start of treatment until disease progression / recurrence.

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 of 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 method of birth control
* 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 study

Primary outcomes:
measure: Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later
timeFrame: March 2010
Secondary outcomes:
measure: Progression Free Survival (PFS) time
timeFrame: March 2010
measure: Overall Survival (OS) time
timeFrame: March 2010
measure: Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index)
timeFrame: March 2010
measure: Safety and Tolerability
timeFrame: March 2010
Other outcomes:
Locations:
city: Freiburg im Breisgau
country: Germany
facility: University Hospital Freiburg, Dept. of Internal Medicine II
state: Baaden-Wuerttemberg
city: Freiburg im Breisgau
country: Germany
facility: Clinic SanaFontis
Study officials:
affiliation: University Hospital Freiburg
name: Hubert Blum, Prof. Dr. med. Dr. h. c.
role: PRINCIPAL_INVESTIGATOR
References: