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

Pancreatic Cancer Clinical Trial

— THERAPY  

Official title:

Phase I-II Study Evaluating Combined Treatment of Cetuximab and Trastuzumab in Metastatic Pancreatic Cancer Patients Progressing After Gemcitabine Based Chemotherapy.(THERAPY)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00923299
• Other study ID #: CDR0000636018
• Secondary ID: CLCC-THERAPYRECF
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2008
• Est. completion date: March 2011

Study information

• Verified date: August 2017
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

Primary

• Determine the recommended dose of trastuzumab when given with cetuximab in patients with metastatic pancreatic cancer that progressed after gemcitabine-based chemotherapy. (Phase I)

• Evaluate the objective response rate as assessed by RECIST criteria. (Phase II)

Secondary

• Evaluate the safety profile as assessed by NCI CTCAE v3.0.

• Evaluate progression-free survival.

• Evaluate overall survival.

OUTLINE: This is a multicenter, phase I dose-escalation study of trastuzumab followed by a phase II study.

Patients receive cetuximab IV over 1-2 hours and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• cetuximab
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.
• trastuzumab
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.

Locations

Country	Name	City	State
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & 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, Pèlegrin A. Dual targeting of HER1/EGFR and HER2 with cetuximab and trastuzumab in pati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recommended dose of trastuzumab when given with cetuximab (Phase I)	From baseline to the end of treatment	15 days
Primary	Objective response rate as assessed by RECIST criteria (Phase II)	From baseline to the end of treatment	Approximately 8 weeks
Secondary	Progression-free survival	From baseline to the end of study	Approximately 36 months
Secondary	Overall survival	From baseline to the end of study	Approximately 36 months