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

Phase 2

Completed

• Conditions: Ovarian Cancer Metastatic Recurrent
• Interventions: Drug: NGR-hTNF; Drug: doxorubicin

• Registration Number: NCT00484432
• Lead Sponsor: AGC Biologics 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.

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.

Study Timeline

• Study First Submitted: 2007-06-07
• Study First Submitted QC: 2007-06-07
• Study First Posted: 2007-06-08
• Study Start: 2008-11
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A: NGR-hTNF + doxorubicin	NGR-hTNF	NGR-hTNF plus doxorubicin
A: NGR-hTNF + doxorubicin	doxorubicin	NGR-hTNF plus doxorubicin

Primary Outcome Measures

Name	Time	Method
Antitumor activity defined as response rate	during the study	Evaluated according to Response evaluation criteria in solid tumors (RECIST)

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	during the study	PFS evaluated according to Response evaluation criteria in solid tumors (RECIST)
CA125 (U/mL) measurement	from the randomization, every 6 weeks until the end of treatment	Tumor marker evaluation
Safety according to NCI-CTCAE criteria (version 3)	during the study	To evaluate safety profile related to NGR-hTNF
Overall survival (OS)	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

Trial Locations

Locations (2)

Policlinico Universitario A. Gemelli; 🇮🇹 Rome, Italy

Fondazione San Raffaele del Monte Tabor; 🇮🇹 Milan, Italy