Gemcitabine and Capecitabine With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving more than one drug (combination chemotherapy) together with vaccine therapy may kill more tumor cells. It is not yet known whether chemotherapy is more effective with or without vaccine therapy in treating pancreatic cancer.

PURPOSE: This randomized phase III trial is studying gemcitabine, capecitabine, and vaccine therapy to see how well they work compared with gemcitabine and capecitabine alone in treating patients with locally advanced or metastatic pancreatic cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Liverpool University Hospital
• Treatments: Capecitabine; Gemcitabine; Sargramostim; Vaccines

Criteria

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