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A Phase III Second Line Trial of Patients With Gemcitabine Resistant Advanced Pancreatic Cancer (CONKO-003)

18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Phase III Second Line Trial of Patients With Gemcitabine Resistant Advanced Pancreatic Cancer (CONKO-003)

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.

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.

Type of Study:

Expanded Access

Study Design:


Principal Investigator

Helmut Oettle, PD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CONKO Study Group


Germany: Ethics Commission

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • refractory pancreatic cancer
  • gemcitabine
  • phase III
  • second line
  • Pancreatic Neoplasms