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

• Register: ClinicalTrials.gov
• Last refreshed on: 5 February 2024
• Main ID: NCT02607202
• Date of registration: 16/11/2015
• Prospective Registration: No
• Primary sponsor: Fondazione del Piemonte per l'Oncologia
• Public title: A Study of Nab-paclitaxel-based Doublet as First Line Therapy in Patients With Cancer of Unknown Primary (CUP) AGNOSTOS
• Scientific 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
• Date of first enrolment: March 2015
• Target sample size: 57
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02607202
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Italy

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Unknown Primary Tumors

Intervention(s)

Drug: Gemcitabine

Drug: Carboplatin

Drug: nab-paclitaxel

Primary Outcome(s)

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(s)

overall survival [Time Frame: 42 months]

toxicity according to Common Terminology Criteria for Adverse Events - CTCAE version 4.03. [Time Frame: 42 months]

duration of response according to RECIST version 1.1. [Time Frame: 42 months]

time to progression [Time Frame: 42 months]

Secondary ID(s)

008-IRCC-10IIS-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors