Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine

PD Dr. med. Volker Heinemann

Status and phase

Unknown

Phase 3

Conditions

Pancreatic Cancer

Treatments

Drug: Capecitabine

Drug: Erlotinib

Drug: Gemcitabine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00440167

RC-57 crossover

Details and patient eligibility

About

This crossover trial is performed in advanced and metastatic pancreatic cancer not previously exposed to chemotherapy. The study compares a standard arm with gemcitabine plus erlotinib to an experimental arm with capecitabine plus erlotinib. It is the first trial of its kind to incorporate second-line treatment into the study design. Patient who fail on first-line therapy are switched to the comparator chemotherapy without erlotinib. The trial therefore not only compares two different regimens of first-line treatment, it also compares two sequential treatment strategies.

Enrollment

280 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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