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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Marc Ychou, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Val d'Aurelle - Paul Lamarque

Authority:

Unspecified

Study ID:

CDR0000636018

NCT ID:

NCT00923299

Start Date:

December 2008

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage IV pancreatic cancer
  • recurrent pancreatic cancer
  • adenocarcinoma of the pancreas
  • Pancreatic Neoplasms

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