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

NCT02607202 | Completed Phase 2

• 1 other identifier: 008-IRCC-10IIS-14
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 10

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.

Conditions

Unknown Primary Tumors

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) as evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.

  42 months

Secondary Outcomes (4)

• duration of response according to RECIST version 1.1.

  42 months

• time to progression

  42 months

• overall survival

  42 months

• toxicity according to Common Terminology Criteria for Adverse Events - CTCAE version 4.03.

  42 months

Study Arms (2)

Arm A

EXPERIMENTAL

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; Drug: Gemcitabine

Arm B

EXPERIMENTAL

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; Drug: Carboplatin

Interventions

nab-paclitaxel DRUG

Also known as: Abraxane

Arm A; Arm B

Carboplatin DRUG

Arm B

Gemcitabine DRUG

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (10)

Investigative Clinical Oncology (Oncologia Medica 2)

Candiolo, Turin, 10060, Italy

Location

AOU Policlinoco S Orsola - Malpighi

Bologna, Italy

Location

Ospedali Galliera

Genova, Italy

Location

Istituto Europeo di Oncologia - IEO

Milan, Italy

Location

Istituto Nazionale dei Tumori

Milan, Italy

Location

Ospedale Niguarda Cà Granda

Milan, Italy

Location

Istituto Oncologico Veneto - IOV

Padua, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Location

Policlinico Universitario Campus Biomedico

Roma, Italy

Location

A.O.U S.Giovanni Battista

Torino, 10126, Italy

Location

MeSH Terms

Conditions

Neoplasms, Unknown Primary

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 17, 2015
• Study Start: March 1, 2015
• Primary Completion: May 4, 2021
• Study Completion: January 31, 2022
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

IT (10)