Efficacy and Safety of a Neoadjuvant Treatment in Pancreatic Cancer

Pancreatic Adenocarcinoma Clinical Trial

— GEMCAD1003  

Official title:

Phase II Study Open, Not Randomized to Evaluate the Efficacy and Safety of Neoadjuvant Treatment With Gemcitabine and Erlotinib Followed by Gemcitabine, Erlotinib and Radiotherapy in Patients With Resectable Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389440
• Other study ID #: GEMCAD1003
• Secondary ID: 2010-021738-72
• Status: Completed
• Phase: Phase 2
• Start date: May 2011
• Est. completion date: January 22, 2017

Study information

• Verified date: August 2017
• Source: Grupo Espanol Multidisciplinario del Cancer Digestivo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase II open study, not randomized with a neoadjuvant therapy,combination of Gemcitabine (1,000 mg/m2/week) with Erlotinib (100mg/day) (3 cycles of 4 weeks), followed by gemcitabine (300 mg/m2/week) combined with Erlotinib (100mg/day) and radiotherapy (45 Gy / day fr180 cGy) (5 cycles of 1 week) in patients with resectable pancreatic adenocarcinoma to assess the percentage of R0 resections. They have planned a total of 21 visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 22, 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Able to sign the inform consent form

• Age between 18-75 years

• Subject has not undergone any chemotherapy or radiotherapy previously

• Functional status o-1 (ECOG scale)

• Satisfy all radiological inclusion criteria (MSCT performed 28 days before the treatment starts and a centralized evaluation)

• Patients with a cytologically confirmed diagnosis of pancreatic adenocarcinoma(preferably by EUS)

• Appropriate analytical as inclusion criteria (7 days before the treatment starts):

• bone marrow status: neutrophils = 1,500x10^9/L; platelets = 100x10^9/L; hemoglobin = 9g/dL.

• INR = 1.5 and PTT = 1.5 x upper range of normal.

• Bilirubin = 5 mg/dL

• Albumin> 34 g/L

• Renal function: creatinine = 1.5 mg/dL and creatinine clearance> 50ml/min

Exclusion Criteria:

• patients treated with any of the study's drugs

• patients who has develop other primary tumors in 5 years prior to the inclusion at the clinical trial, except for cervix carcinoma in situ or basal cell skin cancer which have been treated properly.

• significant clinical cardiovascular disease: stroke (= 6 months before the study inclusion), heart attack (= 6 months before inclusion), unstable ango pectoris, congestive heart failure second grade or higher of the New York Heart Association (NYHA) or serious cardiac arrhythmia requiring medication, uncontrolled hypertension

• Total o partial bowel obstruction

• Chronic diarrhea

• Current treatment with another investigational drug or participation in another clinical trial within 30 days prior to inclusion.

• Known hypersensitivity to any of the study drugs or their components

• Currently o recent therapeutic treatment (opposite to prophylactic) with oral or parenteral anticoagulants (full dose) or thrombolytic agents. Patients who receive (or are candidates to receive) anticoagulants for prophylaxis of cardiovascular risk, should continue (or begin) treatment at baseline

• Thromboembolic event history or bleeding in the 6 months prior to treatment.

• Evidence of bleeding diathesis or coagulopathy.

• Serious problems in wounds healing, ulcers or bone fractures.

• Major surgery, open biopsy or significant traumatic injury 28 days before treatment.

• Any other disease, metabolic disorder, physical examination findings or clinical laboratory that provides reasonable evidence for suspecting a disease or condition for which it is contraindicated or patient an experimental drug at high risk of experiencing complications related to treatment .

• Patients undergoing with organ allografts requiring immunosuppressive treatment.

• Pregnant or breastfeeding woman. It requires a negative pregnancy test (serum or urine) within 7 days before previous to treatment.

• Men and women of childbearing potential (including women who have had their last menstrual period in less than 2 years) not using effective contraception precautions

• Positive HIV status

• Addiction to alcohol or other drugs

• Known liver cirrhosis

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

Intervention

Drug:
• Gemcitabine and Erlotinib
Administration of gemcitabine (300mg/m2/weekly)with Erlotinib (100 mg/daily) and radiotherapy (45 Gy/daily) after a period of infusion with a full dose of Gemcitabine (1.000mg/m2/weekly) and Erlotinib (100 mg/daily)

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Santa Creu y Sant Pau, Hospital Sant Pau	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Institut Català d'Oncologia (ICO) de L'Hospitalet	Barcelona
Spain	Instituto Catalán de Oncología	Girona
Spain	Hospital Virgen de la Arrixaca	Murcia
Spain	Clínica Universitaria de Navarra	Pamplona	Navarra
Spain	Clínico Universitario de Valencia	Valencia
Spain	Hospital la Fe de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Espanol Multidisciplinario del Cancer Digestivo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of ancients undergoing with neoadjuvant chemoradiotherapy and R0 resection		3 years
Secondary	To describe the safety of the treatment	Based in safety population, all safety parameters will be analyzed and they will be recorded in lists and spread sheets. Most extreme intensity will be used for the notification of adverse events.; Safety population will include all subjects that have taken at least one study medication dose.	3 years
Secondary	Evaluate the response rate using RECIST criteria		3 years
Secondary	Evaluate the percentage of resectability		3 years
Secondary	Evaluate the percentage of lymphatic nodes removed		3 years
Secondary	Evaluate the percentage of lymphatic nodes involved		3 years
Secondary	Evaluate the pathological regression stage (primary tumor and lymphatic nodes)		3 years
Secondary	Relate RECIST criteria with the pathological regress stage		3 years
Secondary	Measure the progression free survival (time from the inclusion date to the progression of the disease or death)		3 years
Secondary	Evaluate the overall survival time		3 years