A Phase III Second Line Trial in Advanced Pancreatic Cancer CONKO 003
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| ClinicalTrials.gov Identifier: NCT00786058 |
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Expanded Access Status :
Approved for marketing
First Posted : November 5, 2008
Last Update Posted : June 15, 2009
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| Condition or disease | Intervention/treatment |
|---|---|
| Pancreatic Cancer | Drug: OFF in experimental arm |
Gemcitabine (G) given until progressive disease (PD) is still standard therapy in patients with advanced pancreatic cancer. No standard secondline regimen is available after PD. Best supportive care (BSC) is the main option for these patients. Our phase II study (Pelzer et al, ASCO 2002) showed activity of the OFF (Oxaliplatin/Folinic Acid/5-FU) regimen. To confirm these data we started this multicenter phase III study to examine OFF vs. BSC alone.
165 patients were needed for this study. Following CT/ MRT confirmed PD patients were randomized. Stratification included duration of firstline therapy, Karnofsky Performance Status (KPS) and tumor stage. OFF (outpatient regimen): 5-FU 2g/m² (24h)/FA 200 mg/m² (30min) on d1, d8, d15, d22, additional Oxaliplatin 85mg/m² (2h) on day 8 and 22. Rest on day 23 and 42.
| Study Type : | Expanded Access |
| Official Title: | A Phase III Second Line Trial of Patients With Gemcitabine Resistant Advanced Pancreatic Cancer (CONKO-003) |
- Drug: OFF in experimental arm
OFF was given according to a six week cycle. FA (500 mg/m2 , 0.5h, i.v.) and 5-FU (2,600 mg/m2, 24-hour, i.v.) were administered on days 1, 8, 15, and 22. Oxaliplatin (85 mg/m2 , 2-4 h, i.v.) was administered directly before FA/ 5-FU on days 8 and 22.Other Names:
- Eloxatin
- Calciumfolinat
- 5-Fluorouracil
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
Inclusion Criteria:
- Patients with histologically or cytologically confirmed metastatic pancreatic adenocarcinoma that had progressed during first line gemcitabine therapy were eligible for inclusion in the study.
Other inclusion criteria were:
- Age > 18 years
- Karnofsky performance status > 70%
- Bidimensionally measurable reference lesion, adequate laboratory values for hematology (white blood cell [WBC] count > 3.5´109/L, platelet count > 100´109/L), renal function (creatine clearance > 30 ml/min) and hepatic function (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] < 2.5 ´ upper normal limit [UNL] and in the case of liver metastasis < 5 x UNL)
- As well as controlled pain
Exclusion Criteria:
- Patients were excluded from the study if they had any severe concurrent medical condition interfering with planned therapy, serious cardiac disease, sensory/ motor neuropathy > grade 2 or had previous or current malignancies at other origin; besides, pregnant or lactating women were excluded.
- All patients provided written informed consent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00786058
| Principal Investigator: | Helmut Oettle, PD | CONKO Study Group |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Helmut Oettle PHD, CONKO Study group |
| ClinicalTrials.gov Identifier: | NCT00786058 History of Changes |
| Other Study ID Numbers: |
CONKO 003 CCT-NAPN-16751 |
| First Posted: | November 5, 2008 Key Record Dates |
| Last Update Posted: | June 15, 2009 |
| Last Verified: | June 2009 |
Keywords provided by CONKO-Studiengruppe:
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refractory pancreatic cancer gemcitabine phase III second line |
Additional relevant MeSH terms:
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Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |