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Randomized Phase III Trial With Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine in Patients With Advanced Pancreatic Cancer


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

Randomized Phase III Trial With Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine in Patients With Advanced Pancreatic Cancer


Inclusion Criteria:



- Age between 18 and 75 years

- Histologically proven pancreatic cancer stage III or IV (T1-3 N1M0 or T1 3N0 1M1)

- No option for resection with curative intent

- At least one measurable or not measurable lesion (according to RECIST)

- No previous chemotherapy or other systemic tumor therapy

- No previous radiation

- Performance-Status 0-2 according to WHO/ECOG

- Life expectancy of at least 3 months

- Adequate kidney-, liver- and bone marrow function, defined as

- Absolute neutrophil count * 1,5 x 109/l

- Hemoglobin * 8 g/dl

- Thrombocytes * 100 x 109/l

- Bilirubin * 2 x upper norm (with liver mets < 5-fold)

- Serum Creatinine * 1,25 x upper norm

- Creatinine clearance > 30 ml/min (Cockroft/Gault)

- Transaminases * 2,5 x upper norm (with liver mets < 5-fold)

- Possibility of regular long-term follow-up

- Negative pregnancy test in women at childbearing age

- All patients must have signed an informed consent before study entry.

Exclusion Criteria:

- Known secondary cancer other than curatively treated basalioma or carcinoma in situ
of the cervix uteri

- Clinically unstable CNS-metastases

- Known hypersensitivity against study medication

- Severe impairment of renal function (creatinine clearance < 30 ml/min)

- Severe impairment of liver function (bilirubin > 2,0 x above upper norm,
transaminases > 2,5 x upper norm, or with known liver metastasis >5 x upper norm)

- Clinically relevant disease of the cardiovascular system or other vital organs

- Known polyneuropathy

- Known DPD-deficiency (screening not required)

- Simultaneous treatment with the antiviral agent sorivudin or chemically related
agents such as brivudin

- Pregnancy, lactation or lack of reliable contraception in women at childbearing age

- Mental disease, drug- or alcohol abuse

- Participation in another clinical trial within the last 4 weeks

- All other diseases which may prevent adequate participation in the trial

- Indication of lack of compliance with study regulations

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

TTF2

Outcome Description:

Time to treatment failure, after 2nd line (crossover) therapy

Outcome Time Frame:

approximate 6 months after first line treatment

Safety Issue:

No

Principal Investigator

Volker Heinemann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Munich - Klinikum Grosshadern

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

RC-57 crossover

NCT ID:

NCT00440167

Start Date:

June 2006

Completion Date:

December 2012

Related Keywords:

  • Pancreatic Cancer
  • capecitabine
  • gemcitabine
  • Erlotinib
  • pancreatic cancer
  • advanced
  • Pancreatic Neoplasms

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