Cetuximab and Trastuzumab in Treating Patients With Metastatic Pancreatic Cancer That Progressed After Previous Treatment With Gemcitabine

NCT00923299 | Completed Phase 1

• 5 other identifiers: CDR0000636018CLCC-THERAPYRECF0910VA-2008/34EUDRACT-2008-003988-39
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab and trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving cetuximab together with trastuzumab may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of trastuzumab when given together with cetuximab and to see how well it works in treating patients with metastatic pancreatic cancer that progressed after previous treatment with gemcitabine.

Conditions

Pancreatic Cancer

Keywords

stage IV pancreatic cancer; recurrent pancreatic cancer; adenocarcinoma of the pancreas

Outcome Measures

Primary Outcomes (2)

• Recommended dose of trastuzumab when given with cetuximab (Phase I)

  From baseline to the end of treatment

  15 days

• Objective response rate as assessed by RECIST criteria (Phase II)

  From baseline to the end of treatment

  Approximately 8 weeks

Secondary Outcomes (2)

• Progression-free survival

  Approximately 36 months

• Overall survival

  Approximately 36 months

Study Arms (1)

cetuximab, trastuzumab

OTHER

Drug: cetuximab; Drug: trastuzumab

Interventions

cetuximab DRUG

Cetuximab at the initial dose of 400 mg/m² (J1S1) as a 2-hour infusion and then at the 250 mg/m² dose as a 1-hour infusion in subsequent weeks.

cetuximab, trastuzumab

trastuzumab DRUG

Two dose levels of trastuzumab will be evaluated for Phase 1: * Level 1: a loading dose of 3 mg/kg as a 90-minute intravenous infusion at J1S1 and then 1.5 mg/kg as a 30-minute intravenous infusion for all subsequent weekly administrations; * Level 2: a loading dose of 4 mg/kg as a 90-minute intravenous infusion at J1S1 and then 2 mg/kg as a 30-minute intravenous infusion for all subsequent weekly administrations.

cetuximab, trastuzumab

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic adenocarcinoma of the pancreas * Progressed after first-line or adjuvant gemcitabine-based chemotherapy * Measurable disease as assessed by RECIST criteria * No known brain metastasis or symptomatic carcinomatous leptomeningitis PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Life expectancy ≥ 3 months * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Total bilirubin ≤ 2.5 times ULN * ALT/AST ≤ 5 times ULN * LVEF ≥ 55% * Not pregnant or nursing * Fertile patients must use effective contraception * No significant comorbidities, including any of the following: * Cardiovascular disease * Documented history of congestive heart failure * Uncontrolled, high-risk arrhythmia * Angina pectoris requiring treatment * Clinically significant valvular disease * Evidence of transmural myocardial infarction by ECG * Uncontrolled hypertension * Active bleeding * Clinically significant active infection * Severe dyspnea at rest * Oxygen-dependency * No other malignancy except basal cell carcinoma of the skin * No severe hypersensitivity to cetuximab or trastuzumab * No medical or psychological condition that would preclude study completion or giving informed consent * No legal incapacity or limited legal capacity PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior cetuximab or trastuzumab * No other concurrent experimental drugs or anticancer therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Related Publications (1)

• Assenat E, Azria D, Mollevi C, Guimbaud R, Tubiana-Mathieu N, Smith D, Delord JP, Samalin E, Portales F, Larbouret C, Robert B, Bibeau F, Bleuse JP, Crapez E, Ychou M, Pelegrin A. Dual targeting of HER1/EGFR and HER2 with cetuximab and trastuzumab in patients with metastatic pancreatic cancer after gemcitabine failure: results of the "THERAPY"phase 1-2 trial. Oncotarget. 2015 May 20;6(14):12796-808. doi: 10.18632/oncotarget.3473.

  PMID: 25918250 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cetuximab; Trastuzumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Marc Ychou, MD, PhD

  Institut du Cancer de Montpellier - Val d'Aurelle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 18, 2009
• Study Start: December 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: March 1, 2011
• Last Updated: April 16, 2019

Record last verified: 2017-08

Locations

FR (1)