Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian Cancer (NGR018)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by MolMed S.p.A.
Sponsor:
Information provided by (Responsible Party):
MolMed S.p.A.
ClinicalTrials.gov Identifier:
NCT01358071
First received: May 19, 2011
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

The primary objective of this randomized phase II trial is to compare progression-free survival (PFS) in patients randomized to NGR-hTNF plus an anthracycline versus patients randomized to an anthracycline alone


Condition Intervention Phase
Ovarian Cancer
Drug: NGR-hTNF
Drug: Pegylated liposomal doxorubicin
Drug: Doxorubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NGR018: Randomized Phase II Study of NGR-hTNF Plus an Anthracycline Versus an Anthracycline Alone in Platinum-resistant Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by MolMed S.p.A.:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: every 6-8-12 weeks ] [ Designated as safety issue: No ]
    Defined as the time from the date of randomization until disease progression, or death


Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: every 6- 8 -12 weeks ] [ Designated as safety issue: No ]
    Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive

  • Response Rate (RR) [ Time Frame: every 6 - 8 -12 weeks ] [ Designated as safety issue: No ]
    Measured both according to RECIST criteria

  • Disease Control Rate (DCR) [ Time Frame: every 6 - 8 -12 weeks ] [ Designated as safety issue: No ]
    Defined as the percentage of patients who have a best-response rating of complete response, partial response, or stable disease, according to standard RECIST criteria

  • Duration of Disease Control [ Time Frame: every 6 - 8 -12 weeks ] [ Designated as safety issue: No ]
    Measured from the date of randomization until disease progression, or death due to any cause

  • Safety and Toxicity according to NCI-CTCAE criteria (version 4.03) [ Time Frame: During the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 124
Study Start Date: June 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: NGR-hTNF+Pegylated Liposomal Doxorubicin or Doxorubicin Drug: NGR-hTNF
NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion weekly or every 3 or 4 weeks until confirmed evidence of disease progression or unacceptable toxicity occurs
Drug: Pegylated liposomal doxorubicin
50 mg/m² iv every 4 weeks until confirmed evidence of disease progression
Drug: Doxorubicin
60 mg/m^2 iv every 3 weeks for a maximum of 8 cycles
Active Comparator: Arm B: Pegylated Liposomal Doxorubicin or Doxorubicin Drug: Pegylated liposomal doxorubicin
50 mg/m² iv every 4 weeks until confirmed evidence of disease progression
Drug: Doxorubicin
60 mg/m^2 iv every 3 weeks for a maximum of 8 cycles

Detailed Description:

Considering the safety/toxicity profile of NGR-hTNF characterized by mild-to-moderate constitutional symptoms, the reversibility of these adverse events generally occurring only during the infusion time; the absence of overlapping toxicities with chemotherapeutic agents; the safety and preliminary antitumor activity observed in previous trial with doxorubicin; and the objective response rate (RR) registered in a phase II trial in previously treated ovarian cancer patients seems justified to evaluate in a randomized phase II trial the efficacy of NGR-hTNF against a doxorubicin-based option in advanced ovarian cancer patients progressing or recurrent after a standard platinum/taxane-based chemotherapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Histologically-proven ovarian cancer, fallopian tube and primary peritoneal cancer in advanced or metastatic stage
  • Patients previously treated with a maximum of two platinum-based regimen plus paclitaxel and with documented progressive disease on treatment (refractory patient population) or within 6 months from last chemotherapy cycle (resistant patient population)
  • Good clinical Conditions
  • Normal cardiac function
  • Adequate baseline bone marrow, hepatic and renal function
  • At least one (not previously irradiated) target lesion or non-measurable disease only, according to RECIST criteria
  • Patients may have had prior therapy providing the following conditions are met:

    • Surgery and radiation therapy: wash-out period of 14 days
    • Systemic anti-tumor therapy: wash-out period of 21 days

Exclusion Criteria:

  • Patients may not receive any other investigational agents while on study
  • More than two previous chemotherapy lines and previous treatment with anthracycline
  • Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
  • Prolonged QTc interval (congenital or acquired) > 450 ms
  • History or evidence upon physical examination of CNS disease unless adequately treated
  • Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
  • Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
  • Pregnancy or lactation.
  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: NCT01358071

Contacts
Contact: Giovanni Scambia, MD 0

Locations
Italy
Ospedale San Raffaele Recruiting
Milan, Italy, 20132
Contact: Massimo Candiani, MD         
Principal Investigator: Massimo Candiani, MD         
Istituto Europeo di Oncologia Recruiting
Milan, Italy, 20141
Contact: Nicoletta Colombo, MD         
Principal Investigator: Nicoletta Colombo, MD         
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milan, Italy, 20133
Contact: Francesco Raspagliesi, MD         
Principal Investigator: Francesco Raspagliesi, MD         
Sub-Investigator: Domenica Lorusso, MD         
Istituto Nazionale Tumori IRCCS Fondazione "Giovanni Pascale" Recruiting
Naples, Italy, 80131
Contact: Carmela Pisano, MD         
Principal Investigator: Carmela Pisano, MD         
Ospedale S. Maria della Misericordia Recruiting
Perugia, Italy, 06156
Contact: Anna Maria Mosconi, MD         
Principal Investigator: Anna Maria Mosconi, MD         
Policlinico Universitario "Agostino Gemelli" Recruiting
Rome, Italy, 00168
Contact: Giovanni Scambia, MD         
Principal Investigator: Giovanni Scambia, MD         
United Kingdom
Beatson Oncology Centre, Gartnavel Hospital Recruiting
Glasgow, Scotland, United Kingdom, G12 0YN
Contact: Nicholas Reed, MD         
Principal Investigator: Nicholas Reed, MD         
Clatterbridge Centre for Oncology Recruiting
Bebington, Wirral, United Kingdom, CH63 4JY
Contact: Nasim Ali, MD         
Principal Investigator: Nasim Ali, MD         
Sponsors and Collaborators
MolMed S.p.A.
Investigators
Study Director: Antonio Lambiase, MD MolMed S.p.A.
  More Information

No publications provided

Responsible Party: MolMed S.p.A.
ClinicalTrials.gov Identifier: NCT01358071     History of Changes
Other Study ID Numbers: NGR018, 2010-023613-61
Study First Received: May 19, 2011
Last Updated: January 28, 2013
Health Authority: Italy: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by MolMed S.p.A.:
NGR-hTNF
Pegylated liposomal doxorubicin
Doxorubicin
Platinum-resistant
Progression or recurrence Ovarian Cancer
Ovarian Cancer
Advanced or metastatic

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014