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

Institut du Cancer de Montpellier - Val d'Aurelle

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: trastuzumab; Drug: cetuximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00923299

EUDRACT-2008-003988-39

VA-2008/34

RECF0910

CLCC-THERAPY

CDR0000636018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

cetuximab, trastuzumab

Other group

Treatment:

Drug: cetuximab

Drug: trastuzumab