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出境医 / 临床实验 / A Study of Nab-paclitaxel-based Doublet as First Line Therapy in Patients With Cancer of Unknown Primary (CUP) (AGNOSTOS)
A Study of Nab-paclitaxel-based Doublet as First Line Therapy in Patients With Cancer of Unknown Primary (CUP) (AGNOSTOS)
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Unknown Primary Tumors | Drug: nab-paclitaxel Drug: Carboplatin Drug: Gemcitabine | Phase 2 |
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).
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | March 2015 |
| Estimated Primary Completion Date : | September 2018 |
| Estimated Study Completion Date : | December 2018 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
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 |
Outcome Measures
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 ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
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
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date ICMJE | November 16, 2015 | ||
| First Posted Date ICMJE | November 17, 2015 | ||
| Last Update Posted Date | September 5, 2017 | ||
| Study Start Date ICMJE | March 2015 | ||
| Estimated Primary Completion Date | September 2018 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
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 Measures ICMJE | Same as current | ||
| Change History | |||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||
| Current Other Pre-specified Outcome Measures | Not Provided | ||
| Original Other Pre-specified Outcome Measures | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | A Study of Nab-paclitaxel-based Doublet as First Line Therapy in Patients With Cancer of Unknown Primary (CUP) | ||
| Official Title ICMJE | 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 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). | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 2 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Unknown Primary Tumors | ||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Unknown status | ||
| Estimated Enrollment ICMJE |
120 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date ICMJE | December 2018 | ||
| Estimated Primary Completion Date | September 2018 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Italy | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT02607202 | ||
| Other Study ID Numbers ICMJE | 008-IRCC-10IIS-14 | ||
| Has Data Monitoring Committee | No | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Fondazione del Piemonte per l'Oncologia | ||
| Study Sponsor ICMJE | Fondazione del Piemonte per l'Oncologia | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Fondazione del Piemonte per l'Oncologia | ||
| Verification Date | August 2017 | ||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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