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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01281800
Other study ID # 22k/06/08
Secondary ID
Status Recruiting
Phase Phase 2
First received January 17, 2011
Last updated January 21, 2011
Start date August 2008

Study information

Verified date January 2011
Source Institute of Oncology Ljubljana
Contact Viljem Kovac, MD
Phone +386 1 5879 504
Email vkovac@onko-i.si
Is FDA regulated No
Health authority Slovenia: Ethics Committee
Study type Interventional

Clinical Trial Summary

This is a randomised Phase II clinical trial to assess and compare efficacy and safety profile of cisplatin and pemetrexed against cisplatin and low-dose gemcitabine in long infusion.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 mL/min;

- 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
Gemcitabine in long infusion
TREATMENT A: Day 1: Pemetrexed 500 mg/m2 Cisplatin 75 mg/m2 Cycle every 3 weeks. Supportive treatment: folic acid [Tifol 400 mg tbl (350-1000 mg), beginning 7 days before CT, every day, till 3 week after the KT], vitamin B-12 [OH-B12 i.m., beginning in 7 days before CT, than at 3. + 6. cycles of KT + 9. week after the KT], corticosteroids, hydration, antiemetic, LMW heparin as thromboprophylaxis. In the absence of progression, 4 cycles of chemotherapy with pemetrexed and cisplatin will be given, followed by two additional cycles of pemetrexed as monotherapy. TREATMENT B: Days 1 and 8: gemcitabine 250 mg/m2 in 6 hours day 2: cisplatin 75 mg/m2 Cycle every 3 weeks. Supportive treatment: corticosteroids, hydration, antiemetics, LMW heparin as thromboprophylaxis. In the absence of progression, 4 cycles of chemotherapy with gemcitabine and cisplatin will be given, followed by two additional cycles of gemcitabine alone as monotherapy.

Locations

Country Name City State
Slovenia Institute of Oncology Ljubljana Ljubljana

Sponsors (2)

Lead Sponsor Collaborator
Institute of Oncology Ljubljana Slovenian Research Agency

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival 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 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) No
Secondary Overall survival Efficacy of the treatment will be measured also by overall survival (OS).
Safety and tolerability will be assessed by monitoring the adverse events during treatment and follow-up phase and graded according the NCI Common Toxicity Criteria (CTC), version 3.0.
Quality of life (QOL) will be assessed with performance status (Karnofsky) and with Lung Cancer Symptom Scale (LCSS) - Observer and patient scale.
Outcome measures will be assessed during average time period of 18 months from enrollment Yes
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