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Cisplatin With Either Alimta or Gemcitabine in Long Infusion for Mesothelioma: A Randomised Phase II Trial (AGILI Trial)

Phase 2
18 Years
Open (Enrolling)

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Trial Information

Cisplatin With Either Alimta or Gemcitabine in Long Infusion for Mesothelioma: A Randomised Phase II Trial (AGILI Trial)

Combination of pemetrexed and cisplatin is now considered the standard systemic treatment
for mesothelioma. Three arguments against such a position are: 1. Pemetrexed in combination
with cisplatin was registered for mesothelioma on the basis of superiority over cisplatin
alone, a clearly suboptimal control arm; 2. Several Phase II trials of gemcitabine in
standard doses or as low-dose in long infusion in combination with cisplatin have shown at
least comparable activity; 3. Due to high cost, pemetrexed is not available to many patients
in countries with limited health care resources. During the past five years, our research
team in Ljubljana conducted a Phase II trial of low-dose gemcitabine (250 mg/m2) in 6-hours
infusion and cisplatin for patients with mesothelioma. In an unselected population of
patients including those in poor performance status, elderly, patients with advanced
extrathoracic disease and patients in progression after previous chemotherapy, the response
rate was 54%, and median survival was 16.5 months. On the basis of this favourable
experience and in search of cost-effective treatment for mesothelioma, we here propose a
randomised Phase II clinical trial to compare efficacy and safety profile of cisplatin and
pemetrexed against cisplatin and low-dose gemcitabine in long infusion. The primary
endpoints are response rate and time to progression; secondary endpoints are survival,
toxicity and quality of life.

Inclusion Criteria:

- histologically proven mesothelioma. While local histopathology exam is sufficient to
register a patient for the trial, all biopsies will be subject to central review
(please see Section 5.3.)

- no history of other malignancy; or in complete remission for > 3 years if previously
treated for other malignancy;

- chemo-naive;

- performance status ≥ 70% (Karnofsky); or ECOG 0 - 2 ;

- no peripheral neuropathy grade 2 or more (common toxicity criteria - CTC, NCI),
unless mechanical in origin;

- no vascular disease grade 2 or more (NCI CTC ver.3);

- hemoglobin > 100 g/L;

- neutrophils > 2.0 g/L;

- platelets > 100 x 109 /L;

- kidney function: creatinine within normal limits + ECC > 60 mL/min; or ECC > 100

- liver function: bilirubin < 1.25 x UNL; AST/ALT < 2 x UNL;

- cardiac compensation;

- no active infection or other serious concomitant disease;

- women are not pregnant

- patient's understanding of the disease and treatment and written informed consent.

Exclusion Criteria:

• significant medical co-morbidity

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Description:

Efficacy of the treatment will be measured by response rate (RR) and progression free survival (PFS) using modified RECIST criteria for assessment of response in malignant pleural mesothelioma

Outcome Time Frame:

CT measurement of disease will be performed after 2nd cycle of chemotherapy, at the end of the treatment and during follow up period up to progression (total average 8 months)

Safety Issue:


Principal Investigator

Viljem Kovac, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute of Oncology Ljubljana


Slovenia: Ethics Committee

Study ID:




Start Date:

August 2008

Completion Date:

Related Keywords:

  • Mesothelioma
  • Mesothelioma