Status:
TERMINATED
GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer
Lead Sponsor:
Pharmexa A/S
Collaborating Sponsors:
ICON Clinical Research
ORION Clinical Services
Conditions:
Advanced Unresectable Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.
Detailed Description
The trial is a Phase III, multinational, multicentre, controlled, randomised open-label trial. It will involve 520 advanced pancreatic cancer patients. Patients will be randomly assigned to receive Ge...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas.
- Adequate hematological parameters:
- Hemoglobin \>/= 9.5 g/dL \[SI units, 5.9 mmol/L\] WBC \>/= 3000/mm3 \[SI units, \>/= 3 x 109/L\] Platelets \>/= 100,000/mm3 \[SI units, \>/= 100 x 109/L\]
- Adequate baseline liver function:
- Total Bilirubin \< 3x ULN and
- Without liver metastases:
- AST (SGOT) \</= 2.5 x ULN ALT (SGPT) \</= 2.5 x ULN
- With liver metastases:
- AST (SGOT) \</= 5 x ULN ALT (SGPT) \</= 5 x ULN
- Serum creatinine \</= 1.5 mg/dL \[SI units, 132 µmol/L\].
- Performance status ECOG 0-1.
- Male or female 18 - 75 years inclusive.
- Minimum life expectancy of 3 months.
- Written informed consent.
Exclusion
- Treatment with chemotherapy for pancreatic cancer.
- Treatment with other investigational drugs within the last 4 weeks prior to inclusion
- Immune-suppressive therapy \<4 weeks prior to inclusion
- Chronic corticosteroid use except for asthma inhalers / topical use
- Radiotherapy within 8 weeks of randomisation.
- Other prior malignancies except for adequately treated non-melanoma skin cancers (BCC, SCC) and carcinoma in situ of the cervix.
- Known diagnosis of HIV (AIDS), Hepatitis B, C.
- Known history of or co-existing autoimmune disease.
- Known CNS metastases.
- Clinically significant serious disease or organ system disease not currently controlled on present therapy.
- Pregnancy or lactation.
- Women of childbearing potential not using reliable and adequate contraceptive methods\*
- Known sensitivity to any components of vaccine, gemcitabine or GM-CSF.
- Unable for any other reason to comply with the protocol (treatment or assessments).
- Adequate contraceptive methods are defined as the use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; or women who are practising abstinence; or where the partner is sterile, for example a vasectomy.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00358566
Start Date
June 1 2006
End Date
August 1 2008
Last Update
May 19 2008
Active Locations (86)
Enter a location and click search to find clinical trials sorted by distance.
1
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36688
2
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
3
Scripps Clinic Torrey Pines
La Jolla, California, United States, 92037
4
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, United States, 92270