GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer

Stopped early · Phase 3

Conditions studied: Advanced Unresectable Pancreatic Cancer

In brief

To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.

Key facts

Study ID

NCT00358566

Run by

Pharmexa A/S

People needed

360

Starts

2006-06-01

Expected to finish

2008-08-01

Last updated by the study team

2008-05-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Genesis Cancer Center — Hot Springs, Arkansas, United States
• Scripps Clinic Torrey Pines — La Jolla, California, United States
• Desert Hematology Oncology Medical Group, Inc. — Rancho Mirage, California, United States
• The Center for Hematology-Oncology — Boca Raton, Florida, United States
• Tampa General Hospital Usf Digestive Disorders Centre — Tampa, Florida, United States
• Palm Beach Cancer Institute — West Palm Beach, Florida, United States
• Portneuf Cancer Center — Pocatello, Idaho, United States
• Oncology Hematology Associates of Central Illinois, PC — Peoria, Illinois, United States
• Hematology Oncology Specialists, Covington — Covington, Louisiana, United States
• Berskhire Hematology Oncology PC — Pittsfield, Massachusetts, United States
• Billings Clinic — Billings, Montana, United States
• Carolinas Hematology Oncology Associates — Charlotte, North Carolina, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Toledo Community Hospital Oncology Program — Toledo, Ohio, United States
• Southwest Regional Cancer Center — Austin, Texas, United States
• Mary Crowley Medical Research Center (MCMRC)Texas Oncology-Presbyrerian Hospital of Dallas — Dallas, Texas, United States
• Mary Crowley Medical Research Center, Worth St. — Dallas, Texas, United States
• Oncology Consultants, PA — Houston, Texas, United States
• St George Hospital, Department of Medical Oncology — Kogarah, New South Wales, Australia
• Westmead Hospital, Dept. of Medical Oncology and Palliative Care — Westmead, New South Wales, Australia
• The Townsville Hospital, Townsville Cancer Centre — Douglas, Queensland, Australia
• Flinders Medical Centre, Medical Oncology - Clinical Trials — Bedford Park, South Australia, Australia
• Dept. of Clinical Haematology / Oncology,the Queen Elizabeth Hospital — Woodville South, South Australia, Australia
• Royal Hobart Hospital, Centre for Clinical Research — Hobart, Tasmania, Australia
• University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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