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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Fondazione del Piemonte per l'Oncologia
Sponsor:
Information provided by (Responsible Party):
Fondazione del Piemonte per l'Oncologia
ClinicalTrials.gov Identifier:
NCT02607202
First received: November 16, 2015
Last updated: August 19, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Unknown Primary Tumors
Drug: nab-paclitaxel
Drug: Carboplatin
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fondazione del Piemonte per l'Oncologia:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: March 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
nab-paclitaxel 125 mg/m2 on Days 1 and 8 by IV administration over 30 minutes without premedication, followed by gemcitabine 1000 mg/m2 on Days 1 and 8 by IV administration over 30 minutes. Treatment to be repeated Q21 days.
Drug: nab-paclitaxel
Other Name: Abraxane
Drug: Gemcitabine
Experimental: Arm B
nab-paclitaxel 125 mg/m2 on Days 1 and 8 by IV administration over 30 minutes without premedication, followed by carboplatin AUC 2 on Day 1 and 8 by IV administration over 60 minutes. Treatment to be repeated Q21 days.
Drug: nab-paclitaxel
Other Name: Abraxane
Drug: Carboplatin

Detailed Description:
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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of written informed consent.
  • Patients must be ≥ 18 years of age.
  • Diagnosis of CUP according to CUP Diagnostic Guidelines derived from ESMO 2011 and NCCN 2015 guidelines.
  • Sufficient archived biopsy tissue from a surgical or core needle biopsy required to perform the CUP multiplex assay.
  • Eastern Cooperative Oncology Group performance status ≤ 2.
  • No previous systemic therapy.
  • At least one measurable lesion by RECIST Criteria.
  • Good liver, cardiac, lung and marrow bone function.
  • Evidence of non-childbearing status for female patients: negative urine or serum pregnancy test within 21 days of study treatment for women of childbearing potential, or postmenopausal status.
  • Patients of child bearing potential and their partners, who are sexually active, must agree to the use of highly effective forms of contraception throughout their participation in the study.
  • Patient is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations.

Exclusion Criteria:

  • Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, breast Ductal Carcinoma in Situ (DCIS), stage 1 grade 1 endometrial carcinoma.
  • Specific treatable CUP syndromes including: extragonadal germ cell syndrome; neuroendocrine carcinoma; adenocarcinoma isolated to axillary lymph nodes (women cancer); peritoneal carcinomatosis (women - ovarian cancer); squamous carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes; single resectable metastasis.
  • Patients receiving any radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry.
  • Patients with symptomatic uncontrolled brain metastases.
  • Major surgery within 2 weeks of starting the study and patients must have recovered from any effects of any major surgery.
  • Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
  • Pregnant or breast feeding women.
  • Immunocompromised patients, eg, patients who are known to be serologically positive for human immunodeficiency virus (HIV).
  • Patients with known hepatic disease (eg, Hepatitis B or C).
  • Previous cancer treatment.
  • Patients currently enrolled in another clinical tria, except AGNOSTOS PROFILING.
  • Patients that are receiving chemotherapy, hormonal therapy (HRT is acceptable) or other novel agents.
  • Patients receiving live virus and bacterial vaccines.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02607202

Contacts
Contact: Filippo MONTEMURRO, MD 011 993 ext 3250 filippo.montemurro@ircc.it
Contact: Elena Geuna, MD 011 993 ext 3250 elena.geuna@ircc.it

Locations
Italy
Investigative Clinical Oncology (Oncologia Medica 2) Recruiting
Candiolo, Turin, Italy, 10060
Contact: Filippo Montemurro, MD    011993 ext 3250    filippo.montemurro@ircc.it   
Contact: Elena Geuna, MD    011993 ext 3250    elena.geuna@ircc.it   
AOU Policlinoco S Orsola - Malpighi Not yet recruiting
Bologna, Italy
Contact: Andrea Ardizzoni, MD         
Ospedali Galliera Not yet recruiting
Genova, Italy
Contact: Alessandra Gennari, MD         
Istituto Europeo di Oncologia - IEO Not yet recruiting
Milano, Italy
Contact: Giuseppe Curigliano, MD         
Istituto Nazionale dei Tumori Not yet recruiting
Milano, Italy
Contact: Filippo De Braud, MD         
Ospedale Niguarda Cà Granda Not yet recruiting
Milano, Italy
Contact: Salvatore Siena, MD         
Istituto Oncologico Veneto - IOV Not yet recruiting
Padova, Italy
Contact: Vittorina Zagonel, MD         
Fondazione IRCCS Policlinico San Matteo Not yet recruiting
Pavia, Italy
Contact: Giulia Stella, MD         
Policlinico Universitario Campus Biomedico Not yet recruiting
Roma, Italy
Contact: Giuseppe Tonini, MD         
A.O.U S.Giovanni Battista Not yet recruiting
Torino, Italy, 10126
Contact: Libero Ciuffreda, MD         
Principal Investigator: Libero Ciuffreda, MD         
Sponsors and Collaborators
Fondazione del Piemonte per l'Oncologia
  More Information

Responsible Party: Fondazione del Piemonte per l'Oncologia
ClinicalTrials.gov Identifier: NCT02607202     History of Changes
Other Study ID Numbers: 008-IRCC-10IIS-14
Study First Received: November 16, 2015
Last Updated: August 19, 2016

Additional relevant MeSH terms:
Neoplasms, Unknown Primary
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 24, 2017