Open-label, Multicenter, Randomized Phase II Trial of Treatment With Cisplatin and Pemetrexed or Cisplatin and Oral Vinorelbine in Chemotherapy Naïve Patients Affected by Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer With High Thymidylate Synthase Expression

Sponsor
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Study ID
NCT02919462
Phase
PHASE2
Status
Terminated

Conditions

  • Advanced Stage IIIB
  • Carcinoma, Non-Small-Cell Lung
  • High Thymidylate Synthase Expression
  • Secondary

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oral vinorelbine — DRUG
    Oral vinorelbine 60-80 mg/m2 on days 1 and 8 (first cycle 60 mg/m2) every 3 weeks, for 4 cycles
  • Cisplatin — DRUG
    Cisplatin 80 mg/m2 on day 1 every 3 weeks, for 4 cycles
  • Maintenance with Metronomic Oral Vinorelbine — DRUG
    Maintenance with Metronomic Oral Vinorelbine 50 mg three times a week on Monday, Wednesday and Friday continuously until disease progression, patient refusal or excessive toxicity (1 cycle: 3 weeks).
  • Pemetrexed — DRUG
    Pemetrexed, 500 mg/m2, day 1 every 3 weeks, for 4 cycles
  • Cisplatin — DRUG
    Cisplatin 75 mg/m2, day 1 every 3 weeks, for 4 cycles
  • Maintenance with Pemetrexed — DRUG
    Maintenance with Pemetrexed 500 mg/m2 day1 q 21 until disease progression (1 cycle: 3 weeks)

Study Details

This is an open-label, multicentre, randomized phase II trial. Eligible patients with Non Small Cell Lung Cancer (NSCLC) with high Thymidylate Synthase (TS) expression , will be randomly assigned with 1:1 ratio to the following treatment Arms: A. 4 cycles of Cisplatin + Oral Vinorelbine followed by maintenance with Metronomic Oral Vinorelbine until disease progression B. 4 cycles of Cisplatin + Pemetrexed followed by maintenance with Pemetrexed until disease progression Treatment will be repeated every 21 days .

Key Dates

Start date
Mar 31, 2016
Status verified
Jan 2018
Primary completion
May 31, 2017
Completion
May 31, 2017

Study Design

Enrollment
2 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm A
    Oral vinorelbine 60-80 mg/m2 on days 1 and 8 (first cycle 60 mg/m2) + Cisplatin 80 mg/m2 on day 1 every 3 weeks, for 4 cycles. Maintenance with Metronomic Oral Vinorelbine 50 mg three times a week on Monday, Wednesday and Friday continuously until disease progression, patient refusal or excessive toxicity (1 cycle: 3 weeks).
  • Active Comparator: Treatment Arm B
    Pemetrexed, 500 mg/m2, day 1 + Cisplatin, 75 mg/m2, day 1 every 3 weeks, for 4 cycles. Maintenance with Pemetrexed 500 mg/m2 day1 q 21 until disease progression (1 cycle: 3 weeks). 7-10 days before treatment administration, premedication with vitamin B12 1000µg intramuscular injection (every 9 weeks) and folate 1mg every day should be commenced.

Primary Outcome Measure

Disease Control Rate (DCR) [ Time Frame: up to 36 months ]

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