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A Randomized Phase II Study of Gemcitabine/Cisplatin With or Without Cetuximab to Evaluate the Efficacy in Patients With Locally Advanced or Metastatic EGFR-EGFR-Positive Pancreatic Cancer. SpaCe Trial

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

A Randomized Phase II Study of Gemcitabine/Cisplatin With or Without Cetuximab to Evaluate the Efficacy in Patients With Locally Advanced or Metastatic EGFR-EGFR-Positive Pancreatic Cancer. SpaCe Trial

During the last years, the esocrine pancreatic carcinoma presented a slow but constant
increase of incidence. Chemotherapy determined disappointing results. Gemcitabine determined
a slight advantage in survival and clinical benefit in comparison with gemcitabine with
cisplatin or oxaliplatin Elevated expression of EGFR or its ligand correlates with worse
prognosis in a variety of human cancers including pancreatic cancer. Therefore, blockade of
EGFR activity would provide a novel strategy for the treatment of cancer. Cetuximab (C225)
is a human/murine chimeric monoclonal antibody directed to the EGFR binding site. In a
preclinical setting, Cetuximab has demonstrated anticancer activity both in cell culture
experiments and in "in vivo" tumor xenograft animal model Since the combination of
gemcitabine and cisplatin seems to be the more effective treatment for advanced pancreatic
cancer and Cetuximab may improve activity of this combination we designed this phase II
randomised trial to assess the role of Cetuximab in combination with gemcitabine and
cisplatin in pancreatic cancer.

Inclusion Criteria:

- Age ≥ 18 years

- Histologically confirmed diagnosis of adenocarcinoma of the pancreas

- Locally advanced (non-resectable) or metastatic pancreatic cancer

- Presence of at least one uni-dimensional indicator lesion measurable by CT scan or
MRI in not an irradiated area (RECIST criteria)

- Immunohistochemical evidence or positive EGFR expression prior to study entry in
primary tumor and/or at least one metastasis

- Life expectancy of ≥ 3 months

- Karnofsky performance status of ≥70 at study entry

- Neutrophils ≥ 1.5 x 109/L, platelets ≥100 x 109/L, and hemoglobin ≥ 9 g/dL

- Bilirubin level either normal or < 1.5 x ULN

- ASAT and ALAT ≤ 2.5 X ULN (≤ 5 x ULN if liver metastasis are present)

- Serum creatinine < 1.5 x ULN

- Effective contraception for both, male and female patients if the risk of conception

- Signed written informed consents prior to beginning protocol specific procedures

Exclusion Criteria:

- Brain metastasis

- Previous chemotherapy for locally advanced or metastatic pancreatic cancer

- Adjuvant therapy is allowed if recurrence is documented > 6 months after the end of
adjuvant treatment

- Radiotherapy within 4 weeks prior to study entry

- Concurrent chronic systemic immune therapy

- Any investigational agent(s) 4 weeks prior to entry

- Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or
EGFR targeting therapy

- Clinically relevant coronary artery disease or a history of a myocardial infarction
within the last 12 months

- Known grade 3 or 4 allergic reaction to any of the components of the treatment

- Known drug abuse/ alcohol abuse

- Legal incapacity or limited legal capacity

- Medical or psychological condition which in the opinion of the investigator would not
permit the patient to complete the study or sign meaningful informed consent

- Women who are pregnant or breastfeeding

- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ
of the cervix. (Patients with a previous malignancy but without evidence of disease
for ≥ 5 years will be allowed to enter the trial).

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

A subject's survival time will be defined as the time from randomization to the date of his or her death. If the subject has not died, survival will be censored on last date the subject was known to be alive.

Principal Investigator

Stefano Cascinu, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente


Italy: The Italian Medicines Agency

Study ID:




Start Date:

May 2005

Completion Date:

September 2006

Related Keywords:

  • Pancreatic Cancer
  • pancreatic cancer
  • metastatic
  • EGFR
  • locally advanced pancreatic cancer
  • Pancreatic Neoplasms