A Randomized Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventional Therapy in Patients With Refractory Cancer

Conditions

• Reccurent/Metastatic Solid Tumor Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Targeted therapy based on molecular profiling : Imatinib — DRUG
• Tumor biopsy — PROCEDURE
• Standard Chemotherapy — DRUG
• Targeted therapy based on molecular profiling : Everolimus — DRUG
• Targeted therapy based on molecular profiling : Vemurafenib — DRUG
• Targeted therapy based on molecular profiling : Sorafenib — DRUG
• Targeted therapy based on molecular profiling : Erlotinib — DRUG
• Targeted therapy based on molecular profiling : Lapatinib + Trastuzumab — DRUG
• Targeted therapy based on molecular profiling : Dasatinib — DRUG
• Targeted therapy based on molecular profiling : Tamoxifen (or letrozole if contra-indication) — DRUG
• Targeted therapy based on molecular profiling : Abiraterone — DRUG

Study Details

SHIVA is a proof of concept randomized phase II trial which compares two treatment strategies for patients with refractory cancer. From a tumor biopsy, a molecular profile of the disease is established (mutations, amplifications, hormone receptor status). If a molecular abnormality is identified for which an approved targeted agent is available, patients are randomized randomized between two arms: * Targeted therapy based on the molecular profile * Conventional therapy based on investigator's choice. A cross-over is proposed at disease progression.

Key Dates

Start date

Oct 31, 2012

Status verified

Nov 2025

Primary completion

Oct 31, 2016

Completion

Dec 31, 2016

Study Design

Enrollment

742 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Active Comparator: Standard chemotherapy
  Treatment choice is based on Investigator decision.
• Experimental: Personalized treatment
  Targeted therapy based on the patient molecular profil (if there is at least one abnormality that could be targeted) Elligible therapies in this trial are : Imatinib Everolimus Vemurafenib Sorafenib Erlotinib Lapatinib Trastuzumab Dasatinib Tamoxifen (or letrozole if contra-indication) Abiraterone

Primary Outcome Measure

Patient's progression free survival (according RECIST 1.1) of targeted therapy based on molecular profiling versus conventional chemotherapy.