Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian Cancer
Overview[ - collapse ][ - ]
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 |
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Condition | Ovarian Cancer |
Intervention | Drug: NGR-hTNF Drug: Pegylated liposomal doxorubicin Drug: Doxorubicin |
Phase | Phase 2 |
Sponsor | MolMed S.p.A. |
Responsible Party | MolMed S.p.A. |
ClinicalTrials.gov Identifier | NCT01358071 |
First Received | May 19, 2011 |
Last Updated | January 28, 2013 |
Last verified | January 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | May 19, 2011 |
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Last Updated Date | January 28, 2013 |
Start Date | June 2011 |
Estimated Primary Completion Date | February 2014 |
Current 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 |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian Cancer |
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Official Title | NGR018: Randomized Phase II Study of NGR-hTNF Plus an Anthracycline Versus an Anthracycline Alone in Platinum-resistant Ovarian Cancer |
Brief Summary | 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 |
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. |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Ovarian Cancer |
Intervention | 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 |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 124 |
Estimated Completion Date | February 2014 |
Estimated Primary Completion Date | December 2013 |
Eligibility 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. |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Giovanni Scambia, MD |
Location Countries | Italy, United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01358071 |
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Other Study ID Numbers | NGR018 |
Has Data Monitoring Committee | No |
Information Provided By | MolMed S.p.A. |
Study Sponsor | MolMed S.p.A. |
Collaborators | Not Provided |
Investigators | Study Director: Antonio Lambiase, MD MolMed S.p.A. |
Verification Date | January 2013 |
Locations[ + expand ][ + ]
Ospedale San Raffaele | Milan, Italy, 20132 Contact: Massimo Candiani, MDPrincipal Investigator: Massimo Candiani, MD Recruiting |
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Istituto Europeo di Oncologia | Milan, Italy, 20141 Contact: Nicoletta Colombo, MDPrincipal Investigator: Nicoletta Colombo, MD Recruiting |
Fondazione IRCCS Istituto Nazionale dei Tumori | Milan, Italy, 20133 Contact: Francesco Raspagliesi, MDPrincipal Investigator: Francesco Raspagliesi, MD Recruiting |
Istituto Nazionale Tumori IRCCS Fondazione "Giovanni Pascale" | Naples, Italy, 80131 Contact: Carmela Pisano, MDPrincipal Investigator: Carmela Pisano, MD Recruiting |
Ospedale S. Maria della Misericordia | Perugia, Italy, 06156 Contact: Anna Maria Mosconi, MDPrincipal Investigator: Anna Maria Mosconi, MD Recruiting |
Policlinico Universitario "Agostino Gemelli" | Rome, Italy, 00168 Contact: Giovanni Scambia, MDPrincipal Investigator: Giovanni Scambia, MD Recruiting |
Beatson Oncology Centre, Gartnavel Hospital | Glasgow, Scotland, United Kingdom, G12 0YN Contact: Nicholas Reed, MDPrincipal Investigator: Nicholas Reed, MD Recruiting |
Clatterbridge Centre for Oncology | Bebington, Wirral, United Kingdom, CH63 4JY Contact: Nasim Ali, MDPrincipal Investigator: Nasim Ali, MD Recruiting |