Gemcitabine/Cisplatin +/-Cetuximab in Patients With Locally Advanced or Metastatic EGFR-Positive Pancreatic Cancer

NCT00536614 | Completed Phase 2

• 1 other identifier: 2004-004309-69
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 10

Brief Summary

This is multicenter, open-label, randomized, phase II trial in patients with locally advanced or metastatic pancreatic cancer. Primary objective: objective response rate. Secondary objectives: safety, time to disease progression, median duration of response, time to treatment failure, overall survival time, correlation between bio-pathological characterization (EGFR, akt, MAPks) objective response and survival

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; metastatic; EGFR; locally advanced pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  A subject's survival time will be defined as the time from randomization to the date of his or her death. If the subject has not died, survival will be censored on last date the subject was known to be alive.

Secondary Outcomes (1)

• response to treatment, and toxicity

  the time from randomization until the date of discontinuation of treatment or progression or death

Study Arms (1)

A

NO INTERVENTION

arm A) gemcitabine/cisplatin in combination with Cetuximab arm B) gemcitabine/cisplatin alone

Genetic: cetuximab

Interventions

cetuximab GENETIC

Cetuximab is an EGFR antibody inhibitor; it has been shown to increase the activity of gemcitabine (GEM) in advanced pancreatic cancer.

A

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Histologically confirmed diagnosis of adenocarcinoma of the pancreas
• Locally advanced (non-resectable) or metastatic pancreatic cancer
• Presence of at least one uni-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area (RECIST criteria)
• Immunohistochemical evidence or positive EGFR expression prior to study entry in primary tumor and/or at least one metastasis
• Life expectancy of ≥ 3 months
• Karnofsky performance status of ≥70 at study entry
• Neutrophils ≥ 1.5 x 109/L, platelets ≥100 x 109/L, and hemoglobin ≥ 9 g/dL
• Bilirubin level either normal or \< 1.5 x ULN
• ASAT and ALAT ≤ 2.5 X ULN (≤ 5 x ULN if liver metastasis are present)
• Serum creatinine \< 1.5 x ULN
• Effective contraception for both, male and female patients if the risk of conception exists
• Signed written informed consents prior to beginning protocol specific procedures

You may not qualify if:

• Brain metastasis
• Previous chemotherapy for locally advanced or metastatic pancreatic cancer
• Adjuvant therapy is allowed if recurrence is documented \> 6 months after the end of adjuvant treatment
• Radiotherapy within 4 weeks prior to study entry
• Concurrent chronic systemic immune therapy
• Any investigational agent(s) 4 weeks prior to entry
• Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy
• Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
• Known grade 3 or 4 allergic reaction to any of the components of the treatment
• Known drug abuse/ alcohol abuse
• Legal incapacity or limited legal capacity
• Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
• Women who are pregnant or breastfeeding
• Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial).

Sponsors & Collaborators

• Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente: lead
• Mario Negri Institute for Pharmacological Research: collaborator

Study Sites (10)

A.O. Ospedale Umberto I - Università - Località Torretta

Ancona, Ancona, 60020, Italy

Location

Ospedali Riuniti, Largo Barozzi, 1

Bergamo, Bergamo, 24128, Italy

Location

A.O. Treviglio-Caravaggio, P.le Ospedale n1

Treviglio, Bergamo, 24047, Italy

Location

Casa di Cura di Poliambulanza, Via Bissolati 57

Brescia, Brescia, 25100, Italy

Location

A.O. Careggi-Università, Viale Pieraccini, 17

Florence, Firenze, 50139, Italy

Location

Azienda USL 6 - Viale Alfieri, 36

Livorno, Livorno, 57121, Italy

Location

A.O. Carlo Poma - Via Albertoni, 1

Mantova, Mantova, 46100, Italy

Location

A.O. Cà Granda, Piazza Ospedale Maggiore, 3

Milan, Milano, 20162, Italy

Location

Ospedale S.Gerardo, Via Donizetti, 106

Monza, Milano, 20052, Italy

Location

Università Campus Biomedico, Via Emilio Longoni, 83

Roma, Roma, 00155, Italy

Location

Related Publications (1)

• Cascinu S, Berardi R, Labianca R, Siena S, Falcone A, Aitini E, Barni S, Di Costanzo F, Dapretto E, Tonini G, Pierantoni C, Artale S, Rota S, Floriani I, Scartozzi M, Zaniboni A; Italian Group for the Study of Digestive Tract Cancer (GISCAD). Cetuximab plus gemcitabine and cisplatin compared with gemcitabine and cisplatin alone in patients with advanced pancreatic cancer: a randomised, multicentre, phase II trial. Lancet Oncol. 2008 Jan;9(1):39-44. doi: 10.1016/S1470-2045(07)70383-2.

  PMID: 18077217 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Stefano Cascinu, MD

  Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: September 28, 2007
• Study Start: May 1, 2005
• Study Completion: September 1, 2006
• Last Updated: September 28, 2007

Record last verified: 2007-09

Locations

IT (10)