Clinical Trial: A Study of Nab-paclitaxel-based Doublet as First Line Therapy in Patients With Cancer of Unknown Primary (CUP)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II, Randomized, Multicenter Study to Assess the Efficacy of Nab-paclitaxel-based Doublet as First Line Therapy in Patients With Cancer of Unknown Primary (CUP): The AGNOSTOS Trial

Brief Summary: Agnostos Trial is a multicentric phase 2 randomized trial with a 'pick-the-winner design' in chemonaive patients with cancer of unknown primary. It will assess the efficacy of the two best active single agent - carboplatin or gemcitabine - added to an innovative taxane back bone (nab-Paclitaxel). Agnostos trial is a part of a larger clinical and translational initiative to improve the outlook of patients with cancer of unknown primary through evaluation of novel chemotherapeutic regimens.

Detailed Summary: Treatment-naïve patients with CUP diagnosis confirmed according to CUP Diagnostic Guidelines, will be enrolled into AGNOSTOS trial. Patients will be randomized upfront to receive a nab-paclitaxel-based duplet adding either carboplatin or gemcitabine until progression or unacceptable toxicity (randomization 1:1, n= 120; 60 per arm).
Sponsor: Fondazione del Piemonte per l'Oncologia

Current Primary Outcome: Objective response rate (ORR) as evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. [ Time Frame: 42 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • duration of response according to RECIST version 1.1. [ Time Frame: 42 months ]
  • time to progression [ Time Frame: 42 months ]
  • overall survival [ Time Frame: 42 months ]
  • toxicity according to Common Terminology Criteria for Adverse Events - CTCAE version 4.03. [ Time Frame: 42 months ]


Original Secondary Outcome: Same as current

Information By: Fondazione del Piemonte per l'Oncologia

Dates:
Date Received: November 16, 2015
Date Started: March 2015
Date Completion: December 2018
Last Updated: August 19, 2016
Last Verified: August 2016