Know Cancer

forgot password

A Randomized Phase II Study of Gemcitabine/Cisplatin With or Without Sorafenib to Evaluate the Efficacy and Safety in Patients With Locally Advanced or Metastatic Pancreatic Cancer. MAPS Trial

Phase 2
18 Years
75 Years
Open (Enrolling)
Locally Advanced Pancreatic Cancer

Thank you

Trial Information

A Randomized Phase II Study of Gemcitabine/Cisplatin With or Without Sorafenib to Evaluate the Efficacy and Safety in Patients With Locally Advanced or Metastatic Pancreatic Cancer. MAPS Trial

Up to date no standard treatment is available for pancreatic cancer. Although gemcitabine
is commonly used in patients with pancreatic cancer with the purpose of symptom palliation,
there is no clear evidence of efficacy in terms of survival increase or progression
control. Furthermore, attempts at improving results by combining gemcitabine with other
cytotoxic drugs failed to obtain any advantage. Recently, an EGFR inhibitor (erlotinib)
showed a small survival advantage when combined with gemcitabine. results obtained with a
combination of gemcitabine and oxaliplatin seem more promising. A meta-analysis of
randomised trials comparing gemcitabine versus gemcitabine and platinum analogues showed a
statistical significant survival advantage for the combination.

Sorafenib is an inhibitor of the RAS/RAF signalling pathway. Furthermore, sorafenib is able
to inhibit both VEGFR and PDGFR.

Since RAS and RAF mutations are quite common in pancreatic cancer, Sorafenib could be useful
in the management of these tumours. Furthermore, it may be combined with gemcitabine and
cisplatin without any pharmacokinetic interaction or enhanced toxicity.

Inclusion Criteria:

- Signed written informed consent prior to beginning protocol specific procedures

- Male or female 18 to 75 years of age

- Diagnosis of histologically confirmed 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)

- 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

- Amylase and lipase ≤ 1.5 x the upper limit of normal

- PT or INR and PTT < 1.5 x upper limit of normal (subjects who receive
anti-coagulation treatment with an agent such as warfarin or heparin will be allowed
to participate provided that no evidence of underlying abnormality in these
parameters exists).

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

Exclusion Criteria:

- Brain metastases

- Previous chemotherapy for locally advanced or metastatic pancreatic cancer.

- Adjuvant therapy if documented recurrence is within 6 months after the end of
adjuvant treatment)

- Radiotherapy within 4 weeks prior to study entry

- Major surgery within 4 weeks of first dose of study drug

- Concurrent chronic systemic immune therapy

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

- Clinically relevant coronary artery disease or a history of a myocardial infarction
within the last 6 months

- Thrombotic or embolic events such as cerebrovascular accident including transient
ischemic attacks within the past 6 months

- Acute or subacute intestinal occlusion or history of inflammatory bowel disease

- 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

- Acute or subacute intestinal occlusion

- 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:

Progression Free Survival

Outcome Time Frame:

time from randomization date to date of local or regional relapse

Safety Issue:


Principal Investigator

Stefano Cascinu, M.Professor

Investigator Role:

Study Chair

Investigator Affiliation:

GISCAD Foundation


Italy: The Italian Medicines Agency

Study ID:




Start Date:

August 2007

Completion Date:

August 2009

Related Keywords:

  • Locally Advanced Pancreatic Cancer
  • pancreatic cancer
  • advanced or metastatic
  • sorafenib
  • Pancreatic Neoplasms