Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian Cancer (NGR018)
This study is currently recruiting participants.
Verified January 2013 by MolMed S.p.A.
Sponsor:
MolMed S.p.A.
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
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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
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 May 16, 2013