Efficacy and Safety of a Neoadjuvant Treatment in Pancreatic Cancer

NCT01389440 | Completed Phase 2 DMC

• 2 other identifiers: GEMCAD10032010-021738-72
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Pancreatic Adenocarcinoma

Keywords

Resectable pancreatic adenocarcinoma; Gemcitabine; Erlotinib; Radiotherapy; Neoadjuvant treatment

Outcome Measures

Primary Outcomes (1)

• Percentage of ancients undergoing with neoadjuvant chemoradiotherapy and R0 resection

  3 years

Secondary Outcomes (9)

• To describe the safety of the treatment

  3 years

• Evaluate the response rate using RECIST criteria

  3 years

• Evaluate the percentage of resectability

  3 years

• Evaluate the percentage of lymphatic nodes removed

  3 years

• Evaluate the percentage of lymphatic nodes involved

  3 years

Study Arms (1)

Gemcitabine, Erlotinib and radiotherapy

EXPERIMENTAL

Gemcitabine + Erlotinib follow by Gemcitabine + Erlotinib + radiotherapy

Drug: Gemcitabine and Erlotinib

Interventions

Gemcitabine and Erlotinib DRUG

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)

Also known as: Gemcitabine and Tarceva

Gemcitabine, Erlotinib and radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients treated with any of the study's drugs
• Total o partial bowel obstruction
• Chronic diarrhea
• 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

Sponsors & Collaborators

• Grupo Espanol Multidisciplinario del Cancer Digestivo: lead

Study Sites (10)

Clínica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Institut Català d'Oncologia (ICO) de L'Hospitalet

Barcelona, 08007, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Santa Creu y Sant Pau, Hospital Sant Pau

Barcelona, 08041, Spain

Location

Instituto Catalán de Oncología

Girona, 17007, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Hospital la Fe de Valencia

Valencia, 46009, Spain

Location

Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Related Publications (1)

• Maurel J, Sanchez-Cabus S, Laquente B, Gaba L, Visa L, Fabregat J, Poves I, Rosello S, Diaz-Beveridge R, Martin-Richard M, Rodriguez J, Sabater L, Conill C, Cambray M, Reig A, Ayuso JR, Valls C, Ferrandez A, Bombi JA, Gines A, Garcia-Albeniz X, Fernandez-Cruz L. Outcomes after neoadjuvant treatment with gemcitabine and erlotinib followed by gemcitabine-erlotinib and radiotherapy for resectable pancreatic cancer (GEMCAD 10-03 trial). Cancer Chemother Pharmacol. 2018 Dec;82(6):935-943. doi: 10.1007/s00280-018-3682-9. Epub 2018 Sep 17.

  PMID: 30225601 DERIVED

MeSH Terms

Interventions

Gemcitabine; Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Joan Maurel, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 8, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: January 22, 2017
• Last Updated: May 18, 2018

Record last verified: 2017-08

Locations

ES (10)