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

Phase 3

Terminated

• Conditions: Advanced Unresectable Pancreatic Cancer
• Interventions: Drug: Gemcitabine (Chemotherapy); Biological: GV1001

• Registration Number: NCT00358566
• Lead Sponsor: Pharmexa A/S

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 Gemcitabine alone or GV1001 plus GM-CSF followed by addition of Gemcitabine at the time of 1st progression of disease. The experimental treatment is given prior to the current standard treatment in 50% of the patients.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-07-14
• Study First Submitted QC: 2006-07-31
• Study First Posted: 2006-08-01
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-16
• Last Update Posted: 2008-05-19
• Primary Completion: 2008-08
• Study Completion: 2008-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas.

2. 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]

3. 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

4. Serum creatinine </= 1.5 mg/dL [SI units, 132 µmol/L].

5. Performance status ECOG 0-1.

6. Male or female 18 - 75 years inclusive.

7. Minimum life expectancy of 3 months.

8. Written informed consent.

Exclusion Criteria

1. Treatment with chemotherapy for pancreatic cancer.

2. Treatment with other investigational drugs within the last 4 weeks prior to inclusion

3. Immune-suppressive therapy <4 weeks prior to inclusion

4. Chronic corticosteroid use except for asthma inhalers / topical use

5. Radiotherapy within 8 weeks of randomisation.

6. Other prior malignancies except for adequately treated non-melanoma skin cancers (BCC, SCC) and carcinoma in situ of the cervix.

7. Known diagnosis of HIV (AIDS), Hepatitis B, C.

8. Known history of or co-existing autoimmune disease.

9. Known CNS metastases.

10. Clinically significant serious disease or organ system disease not currently controlled on present therapy.

11. Pregnancy or lactation.

12. Women of childbearing potential not using reliable and adequate contraceptive methods*

13. Known sensitivity to any components of vaccine, gemcitabine or GM-CSF.

14. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine	Gemcitabine (Chemotherapy)	Gemcitabine alone treatment.
GV1001	GV1001	GV1001 in sequential combination with Gemcitabine

Primary Outcome Measures

Name	Time	Method
Overall survival time	12 month

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	Time of progression

Trial Locations

Locations (86)

University of South Alabama Mitchell Cancer Institute; 🇺🇸 Mobile, Alabama, United States

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

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