Status:
COMPLETED
Gemcitabine and Capecitabine With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Lead Sponsor:
Royal Liverpool University Hospital
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Va...
Detailed Description
OBJECTIVES: Primary * Determine the efficacy of telomerase peptide vaccine GV1001 when administered concurrently or sequentially with gemcitabine hydrochloride and capecitabine, in terms of survival...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
- Locally advanced or metastatic disease precluding curative surgical resection
- Unidimensionally measurable disease by CT scan
- No intracerebral metastases or meningeal carcinomatosis
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy \> 3 months
- WBC \> 3,000/mm³
- Absolute neutrophil count \> 1,500/mm³
- Platelet count \> 100,000/mm³
- Bilirubin \< 2.0 mg/dL
- Creatinine clearance \> 50 mL/min
- No medical or psychiatric condition that would preclude giving informed consent
- No clinically significant serious disease or organ system disease not currently controlled on present therapy
- No uncontrolled angina pectoris
- Not pregnant or nursing
- Fertile patients must use a condom and ≥ 1 other form of contraception during and for 1 year after completion of study treatment
- No other malignancies or invasive cancers within the past 5 years except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- No known malabsorption syndrome
- No known hypersensitivity to any of the investigational agents
- No dihydropyrimidine dehydrogenase deficiency
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No radiotherapy within the past 4 weeks
- No concurrent medications that could affect immunocompetence (e.g., chronic treatment with long-term steroids or other immunosuppressants for unrelated condition)
- Concurrent short-term steroids for palliation of cancer-related symptoms allowed
- No other concurrent investigational drugs or cytotoxic agents
- No other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids) or chemotherapy for another tumor in patients receiving telomerase peptide vaccine GV1001
- Concurrent low-dose corticosteroids may be allowed
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
1110 Patients enrolled
Trial Details
Trial ID
NCT00425360
Start Date
September 1 2006
End Date
March 1 2013
Last Update
August 26 2013
Active Locations (45)
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1
North Devon District Hospital
Barnstaple, England, United Kingdom, EX31 4JB
2
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom, RG24 9NA
3
Pilgrim Hospital
Boston, England, United Kingdom, PE21 9QT
4
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom, BH7 7DW