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

NCT00484432 | Completed Phase 2

• 2 other identifiers: NGR0122007-000004-33
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Ovarian Cancer Metastatic Recurrent

Keywords

NGR-hTNF; Ovarian cancer; Doxorubicin

Outcome Measures

Primary Outcomes (1)

• Antitumor activity defined as response rate

  Evaluated according to Response evaluation criteria in solid tumors (RECIST)

  during the study

Secondary Outcomes (4)

• Progression Free Survival (PFS)

  during the study

• Overall survival (OS)

  from the date of randomization to the date of death, assessed up to 6 months

• CA125 (U/mL) measurement

  from the randomization, every 6 weeks until the end of treatment

• Safety according to NCI-CTCAE criteria (version 3)

  during the study

Study Arms (1)

A: NGR-hTNF + doxorubicin

EXPERIMENTAL

NGR-hTNF plus doxorubicin

Drug: NGR-hTNF; Drug: doxorubicin

Interventions

NGR-hTNF DRUG

NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every 3 week until confirmed evidence of disease progression or unacceptable toxicity occurs

A: NGR-hTNF + doxorubicin

doxorubicin DRUG

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

A: NGR-hTNF + doxorubicin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• AGC Biologics S.p.A.: lead

Study Sites (2)

Fondazione San Raffaele del Monte Tabor

Milan, Italy

Location

Policlinico Universitario A. Gemelli

Rome, 00168, Italy

Location

Related Publications (1)

• Lorusso D, Scambia G, Amadio G, di Legge A, Pietragalla A, De Vincenzo R, Masciullo V, Di Stefano M, Mangili G, Citterio G, Mantori M, Lambiase A, Bordignon C. Phase II study of NGR-hTNF in combination with doxorubicin in relapsed ovarian cancer patients. Br J Cancer. 2012 Jun 26;107(1):37-42. doi: 10.1038/bjc.2012.233. Epub 2012 May 29.

  PMID: 22644293 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

tumor necrosis factor-alpha, CNGRC fusion protein, human; Doxorubicin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Antonio Lambiase, MD

  AGC Biologics S.p.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2007
• First Posted: June 8, 2007
• Study Start: November 1, 2008
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 27, 2018

Record last verified: 2018-08

Locations

IT (2)