Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Phase II Study of Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Patients With Locally Advanced or Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00564720
• Other study ID #: CT/06.13
• Status: Terminated
• Phase: Phase 2
• First received: November 27, 2007
• Last updated: February 14, 2013
• Start date: December 2006
• Est. completion date: March 2011

Study information

• Verified date: February 2013
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial Summary

This randomized phase II trial will compare the efficacy and toxicity of Gemcitabine plus Erlotinib versus Gemcitabine plus Erlotinib plus Oxaliplatin in patients with pancreatic cancer.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 140
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed pancreatic cancer.

• Measurable disease.

• Absence of ascites or obstructive jaundice.

• ECOG Performance Status 0-2.

• Adequate liver kidney and bone marrow function.

• Written informed consent.

Exclusion Criteria:

• Chronic diarrheic syndrome.

• Uncontrolled brain metastases after radiation.

• Liver infiltration over 50%.

• Peripheral neuropathy = 2.

• No second primary malignancy within the past 5 years, except non-melanomas skin cancer or in situ carcinoma of the cervix.

• No active uncontrolled infection.

• Active cardiac disease : unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure > class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.

• Women who are pregnant or lactating.

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine
Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles
• Gemcitabine
Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles
• Erlotinib
Erlotinib 100 mg by mouth (p.o.), daily until disease progression
• Oxaliplatin
Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Department of Medical Oncology	Alexandroupolis
Greece	Air Forces Military Hospital of Athens	Athens
Greece	Errikos Ntynan General Hospital	Athens
Greece	IASO General Hospital of Athens, 1st Department of Medical Oncology	Athens
Greece	Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine	Athens
Greece	Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology	Athens
Greece	State General Hospital of Larissa	Larissa
Greece	Diabalkaniko General Hospital of Thessaloniki	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		1 year survival	No
Secondary	Progression free interval		1 year	No
Secondary	Response rate		Objective responses confirmed by CT or MRI on 3rd and 6th cycle	No
Secondary	Toxicity profile		Toxicity assessment on each chemotherapy cycle	Yes
Secondary	Symptoms improvement		Assessment every two cycles	No