Pancreatic CancerNCT00786058
A Phase III Second Line Trial in Advanced Pancreatic Cancer CONKO 003
A study testing OFF in experimental arm in people with Pancreatic Cancer, run by CONKO-Studiengruppe.
Trial summary
The purpose of this study is to compare best supportive care plus oxaliplatin/ folinic acid/ 5-FU versus best supportive alone in patients with gemcitabine refractory pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- OFF in experimental arm
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: A Phase III Second Line Trial of Patients With Gemcitabine Resistant Advanced Pancreatic Cancer (CONKO-003)
The purpose of this study is to compare best supportive care plus oxaliplatin/ folinic acid/ 5-FU versus best supportive alone in patients with gemcitabine refractory pancreatic cancer.
Read the detailed description
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.
- Conditions
- Pancreatic Cancer
- Being tested
- OFF in experimental arm
- Keywords
- refractory pancreatic cancer, gemcitabine, phase III, second line
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFF in experimental armDrug
Also called Eloxatin, Calciumfolinat, 5-Fluorouracil
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- CONKO-Studiengruppe
- Sponsor type
- University, hospital or other
- Investigators
- Helmut Oettle, PD, Principal investigator, CONKO Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786058
- Sponsor's protocol ID
- CONKO 003
- Other IDs
- CCT-NAPN-16751
- Status last verified
- Jun 2009
- First submitted
- 4 Nov 2008
- Last updated
- 15 Jun 2009
- Results posted
- No
Publications
Oettle H, Riess H, Stieler JM, Heil G, Schwaner I, Seraphin J, Gorner M, Molle M, Greten TF, Lakner V, Bischoff S, Sinn M, Dorken B, Pelzer U. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial. J Clin Oncol. 2014 Aug 10;32(23):2423-9. doi: 10.1200/JCO.2013.53.6995. Epub 2014 Jun 30.
PubMed 24982456
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Second Line Trial of Patients With Gemcitabine Resistant Advanced Pancreatic Cancer (CONKO-003)
- ClinicalTrials.gov ID
- NCT00786058
- Acronym / sponsor ID
- CONKO 003
- Conditions
- Pancreatic Cancer
- Keywords
- refractory pancreatic cancer, gemcitabine, phase III, second line
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- CONKO-StudiengruppeUniversity, hospital or other
- Collaborators
- Sanofi, medac GmbH, Amgen
- First posted
- 5 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare best supportive care plus oxaliplatin/ folinic acid/ 5-FU versus best supportive alone in patients with gemcitabine refractory pancreatic cancer.
Detailed description
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histologically or cytologically confirmed metastatic pancreatic adenocarcinoma that had progressed during first line gemcitabine therapy were eligible for inclusion in the study.
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OFF in experimental armAlso: Eloxatin, Calciumfolinat, 5-FluorouracilOFF 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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2009.
- Derived from this study: PubMed 24982456Oettle H, Riess H, Stieler JM, Heil G, Schwaner I, Seraphin J, Gorner M, Molle M, Greten TF, Lakner V, Bischoff S, Sinn M, Dorken B, Pelzer U. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial. J Clin Oncol. 2014 Aug 10;32(23):2423-9. doi: 10.1200/JCO.2013.53.6995. Epub 2014 Jun 30.
- Related InfoLink provided by the sponsor.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helmut Oettle, PD principal investigator
CONKO Study Group
Questions about this trial
What is this clinical trial studying?
A study testing OFF in experimental arm in people with Pancreatic Cancer, run by CONKO-Studiengruppe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00786058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2009.