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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00440167
• Other study ID #: RC-57 crossover
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 22, 2007
• Last updated: July 5, 2012
• Start date: June 2006
• Est. completion date: December 2012

Study information

• Verified date: July 2012
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine
Gemcitabine 1000 mg/m², d 1, 8 , 15, q d28
• Capecitabine
Capecitabine 2 x 1000 mg/m²/ d oral, d 1 - 14 followed by 7 days Pause ("Flat Dosing")
• Erlotinib
Erlotinib 150 mg/d oral, daily without break

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
PD Dr. med. Volker Heinemann	Roche Pharma AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TTF2	Time to treatment failure, after 2nd line (crossover) therapy	approximate 6 months after first line treatment	No
Secondary	TTF1	Time to treatment failure	approximate 6 months after randomization	No
Secondary	Remission Rate		approximate 6 months after randomization	No
Secondary	Overall Survival		42 months after randomization	No
Secondary	Clinical Benefit Response		approximate 6 months after randomization	No
Secondary	Tumor marker CA19-9 characteristics		approximate 6 months after randomization	No
Secondary	Quality of Life		approximate 6 months after randomization	No
Secondary	Toxicity		approximate 6 months after randomization	Yes