Gemcitabine (GFF) in Patients With Pancreatic Cancer
This study has been completed.
Sponsor:
CONKO-Studiengruppe
Collaborator:
Eli Lilly and Company
Information provided by:
CONKO-Studiengruppe
ClinicalTrials.gov Identifier:
NCT00919282
First received: June 9, 2009
Last updated: June 11, 2009
Last verified: June 2009
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Purpose
The purpose of this study is to examine the efficacy and safety of the drug combination GFF in patients with advanced pancreatic cancer (APC).
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Pancreatic Cancer |
Drug: gemcitabine, folinic acid, 5-FU |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi Center Phase II Study of 5-Fluorouracil/ Folinic Acid Plus Gemcitabine in Patients With Advanced Pancreatic Cancer. |
Resource links provided by NLM:
Drug Information available for:
Fluorouracil
Folic acid
Leucovorin calcium
Levoleucovorin
Gemcitabine
Gemcitabine hydrochloride
U.S. FDA Resources
Further study details as provided by CONKO-Studiengruppe:
Primary Outcome Measures:
- overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- safety of treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 78 |
| Study Start Date: | September 1997 |
| Study Completion Date: | December 2002 |
| Primary Completion Date: | July 2000 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Gemcitabine/folinic acid/5-FU
Gemcitabine 1g/m² 5-FU 750mg/m² FS 500 mg/m²
|
Drug: gemcitabine, folinic acid, 5-FU
gemcitabine 1g/m² - 30 minutes folinic acid 500mg/m² - 2 hours 5-FU 750mg/m² - over 24hours
Other Names:
|
Detailed Description:
This open-label, multi center phase II study was conducted to investigate the efficacy and safety of the combination of 5-Fluorouracil (5-FU)/folinic acid (FA) plus gemcitabine (GFF) in patients (pts) with advanced pancreatic cancer (APC). We consequently started this study after completing the phase I trial accomplished by our CONKO- study group.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- histological proved pancreatic cancer
- inoperable disease
- informed consent
- adequate bone marrow reserve
Exclusion Criteria:
- under 18 years
- brain metastasis
- lactating woman
- life expectancy under 3 months
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | CONKO-Studiengruppe, Universitätsmedizin Berlin |
| ClinicalTrials.gov Identifier: | NCT00919282 History of Changes |
| Other Study ID Numbers: | CONKO 002 pilot |
| Study First Received: | June 9, 2009 |
| Last Updated: | June 11, 2009 |
| Health Authority: | Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices Germany: Federal Ministry of Education and Research |
Keywords provided by CONKO-Studiengruppe:
|
pancreatic cancer gemcitabine combination |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Fluorouracil Gemcitabine Leucovorin Folic Acid Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents Hematinics Hematologic Agents |
ClinicalTrials.gov processed this record on June 18, 2013