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Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Advanced or Metastatic Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00484432
Recruitment Status : Completed
First Posted : June 8, 2007
Last Update Posted : September 27, 2018
Information provided by (Responsible Party):
MolMed S.p.A.

Brief Summary:
The main objective of the trial is to document the response rate in patients affected by metastatic ovarian cancer, treated with NGR-hTNF plus doxorubicin. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Metastatic Recurrent Drug: NGR-hTNF Drug: doxorubicin Phase 2

Detailed Description:
This is a phase II, open-label,single arm, non-randomized study that will be conducted in patients affected by metastatic ovarian cancer, that will be conducted using Simon's two-stage design method.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NGR012: A Phase II Study of NGR-hTNF Administered in Combination With Doxorubicin Every 3 Weeks in Patients Affected by Advanced or Metastatic Ovarian Cancer
Actual Study Start Date : November 2008
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: A: NGR-hTNF + doxorubicin
NGR-hTNF plus doxorubicin
Drug: NGR-hTNF
NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every 3 week until confirmed evidence of disease progression or unacceptable toxicity occurs

Drug: doxorubicin
Doxorubicin: 60mg/m² every 3 weeks, until cumulative dose of 550 mg/m²

Primary Outcome Measures :
  1. Antitumor activity defined as response rate [ Time Frame: during the study ]
    Evaluated according to Response evaluation criteria in solid tumors (RECIST)

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: during the study ]
    PFS evaluated according to Response evaluation criteria in solid tumors (RECIST)

  2. Overall survival (OS) [ Time Frame: from the date of randomization to the date of death, assessed up to 6 months ]
    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

  3. CA125 (U/mL) measurement [ Time Frame: from the randomization, every 6 weeks until the end of treatment ]
    Tumor marker evaluation

  4. Safety according to NCI-CTCAE criteria (version 3) [ Time Frame: during the study ]
    To evaluate safety profile related to NGR-hTNF

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients ≥18 years old affected by advanced or metastatic ovarian cancer previously treated with platinum regimens (cis or carboplatin) plus paclitaxel and with documented progression disease within 6 months from last chemotherapy administered (refractory/resistant population) or in progression disease after 6 months from last chemotherapy (platinum regimens plus paclitaxel) administered
  • Rechallenge with platinum regimens
  • No previous exposure to anthracyclines
  • Histologically or cytologically confirmed ovarian carcinoma
  • Life expectancy more than 3 months
  • ECOG Performance status 0 - 1
  • Normal cardiac function (LVEF ≥55%) and absence of uncontrolled hypertension
  • Measurable disease defined as ≥1 unidimensional measurable lesion ≥ 20 mm by conventional technics or ≥ 10 mm ( spiral CT scan or PET); ascites is allowed if present with peritoneal carcinosis
  • Adequate baseline bone marrow, hepatic and renal function, defined as follows:

    • Neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L
    • Bilirubin < 1.5 x ULN
    • AST and/or ALT < 2.5 x ULN in absence of liver metastasis
    • AST and/or ALT < 5 x ULN in presence of liver metastasis
    • Serum creatinine < 1.5 x ULN
  • Patients may have had prior therapy providing the following conditions are met:

    • Chemotherapy and radiotherapy: wash-out period of 28 days
    • Surgery: wash-out period of 14 days
  • Absence of any conditions in which hypervolaemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (take as reference "Technical data sheet human albumin" specifically used in Pharmacy Department for NGR-hTNF dilution)
  • Patients must give written informed consent to participate in the study

Exclusion criteria:

  • Concurrent anticancer therapy
  • Patients must not receive any other investigational agents while on study
  • New York Heart Association class II-IV cardiac disease
  • Acute angina
  • Patients with myocardial infarction within the last six (6) months
  • Patient with significant peripheral vascular disease
  • Thrombosis of main portal vein
  • Clinical signs of CNS involvement
  • 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. Patients with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00484432

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Fondazione San Raffaele del Monte Tabor
Milan, Italy
Policlinico Universitario A. Gemelli
Rome, Italy, 00168
Sponsors and Collaborators
MolMed S.p.A.
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Study Director: Antonio Lambiase, MD MolMed S.p.A.

Publications of Results:
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Responsible Party: MolMed S.p.A. Identifier: NCT00484432     History of Changes
Other Study ID Numbers: NGR012
2007-000004-33 ( EudraCT Number )
First Posted: June 8, 2007    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: August 2018
Keywords provided by MolMed S.p.A.:
Ovarian cancer
Additional relevant MeSH terms:
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Liposomal doxorubicin
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action