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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

NCT02919462 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2018-01-16

No results posted yet for this study

Summary

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 .

Conditions

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

Interventions

DRUG

Oral vinorelbine

Oral vinorelbine 60-80 mg/m2 on days 1 and 8 (first cycle 60 mg/m2) every 3 weeks, for 4 cycles

DRUG

Cisplatin

Cisplatin 80 mg/m2 on day 1 every 3 weeks, for 4 cycles

DRUG

Maintenance with Metronomic Oral Vinorelbine

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).

DRUG

Pemetrexed

Pemetrexed, 500 mg/m2, day 1 every 3 weeks, for 4 cycles

DRUG

Cisplatin

Cisplatin 75 mg/m2, day 1 every 3 weeks, for 4 cycles

DRUG

Maintenance with Pemetrexed

Maintenance with Pemetrexed 500 mg/m2 day1 q 21 until disease progression (1 cycle: 3 weeks)

Sponsors & Collaborators

  • Pierre Fabre Laboratories

    collaborator INDUSTRY

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

    lead OTHER

Principal Investigators

  • Claudio Dazzi, MD · UOC Oncologia Medica - PO di Ravenna - AUSL della Romagna-RAVENNA Viale Randi 5 - 48121 Ravenna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02919462 on ClinicalTrials.gov