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Chemoradiation With Gemcitabine in Combination With Panitumumab for Patients With Locally Advanced Pancreatic Cancer

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

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Trial Information

Chemoradiation With Gemcitabine in Combination With Panitumumab for Patients With Locally Advanced Pancreatic Cancer

This is a phase I/II, multi-center dose escalation study.

Phase I:

Patients will be enrolled in cohorts of 3 per dose level until the MTD of panitumumab has
been established.

Phase II:

Up to approximately 56 patients will be treated at the MTD level of panitumumab as
established in the phase I part of the study.

Based on the historic data of patients with pancreatic cancer treated with gemcitabine based
chemoradiation, we aim to increase the number of patients who are alive and progression free
at 7 months from the historical value of 50% to 70% with the combination treatment of
chemoradiation plus panitumumab.

Inclusion Criteria:

- Histological or cytological confirmed pancreatic cancer.

- Not eligible for curative resection.

- No distant metastases present.

- Previously untreated with chemotherapy and anti-cancer biologicals for current

- No other current malignant disease, except for basal cell carcinoma of the skin.

- Measurable or evaluable disease as defined by RECIST 1.1 criteria.

- Performance status 0-2 Eastern Cooperative Oncology Group (ECOG) Performance Status
(PS) Scale.

- Age ≥ 18 years.

- Adequate haematological and biological functions:

- Bone marrow function:

1. Neutrophils ≥ 1.5 x 109/L

2. Platelets ≥ 100 x 109/L

3. Hb ≥ 6 mmol/L

- Hepatic function:

1. AST/ALT and alkaline phosphatase (ALP) ≤ 2.5 x institutional upper limit of
normal (ULN)

2. Bilirubin ≤ 1.5 times institutional ULN

- Renal function:

eGFR >50ml/min

• Metabolic Function:

1. Magnesium ≥ lower limit of normal

2. Calcium ≥ lower limit of normal.

- No imminent bowel obstruction.

- No active bleeding.

- No uncontrolled infection.

- Patients with reproductive potential must use effective contraception. Female
patients must have a negative pregnancy test.

- Signed informed consent.

Exclusion Criteria:

- Participation in another therapeutic clinical study within 30 days of enrollment or
during this clinical study.

- No adequate radiation therapy possible: based on the opinion of the radiation
oncologist when radiation therapy cannot be performed because radiation field is too
large (PTV volume too large or OAR too high)

- History of allergic reactions to gemcitabine or antibody treatment.

- Presence of any serious concomitant systemic disorders incompatible with the clinical
study (e.g. uncontrolled inter-current illness including ongoing or active infection,
uncontrolled hypertension).

- Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
arrhythmia) within 1 year before enrolment/randomization

- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or
evidence of interstitial lung disease on baseline chest CT scan

- Presence of any significant central nervous system or psychiatric disorder(s) that
would hamper the patient's compliance.

- Pregnant or breastfeeding women.

- Absence of adequate contraception for both male and female fertile patients for the
duration of the study; and also for six months after last treatment.

- Known positive status for HIV and/or hepatitis B or C.

- Any reason why, in the investigator's opinion, the patient should not participate in
the study.

- Drug or alcohol abuse.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: the recommended safe dosing for the combination of chemoradiation with gemcitabine plus panitumumab.

Outcome Description:

During the phase I part of the study, we have planned to study four dose levels of panitumumab if no MTD is being derived before the final dose level. Patients will be enrolled in cohorts of 3 per dose level. If there are no dose-limiting toxicities (DLTs) experienced by the first 3 patients in a cohort during the first 43 days after the first study treatment, additional patients will be entered in the next dose level. At the final dose level recommended for the phase II study a minimum of 6 patients will be treated.

Outcome Time Frame:

43 days

Safety Issue:


Principal Investigator

Henk MW Verheul, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

VU University Medical Center


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

July 2010

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • Panitumumab
  • Chemoradiation
  • Pancreatic cancer
  • Locally advanced
  • Inoperable
  • Pancreatic Neoplasms