Weekly Paclitaxel With or Without Pazopanib in Platinum Resistant or Refractory Ovarian Cancer (MITO-11)

April 6, 2018 updated by: National Cancer Institute, Naples

MITO-11: A Randomized Multicentre Phase II Trial With Pazopanib and Weekly Paclitaxel vs Weekly Paclitaxel in Platinum Resistant or Refractory Ovarian Cancer

The purpose of this study is to evaluate the safety and activity of adding pazopanib to weekly chemotherapy with paclitaxel for patients with ovarian cancer that is resistant or refractory to treatment with platinum based therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Acquaviva delle Fonti, Italy
        • Osp. Regionale Mulli
      • Arezzo, Italy
        • Ospedale San Donato
      • Benevento, Italy
        • A.O. G. Rummo
      • Bologna, Italy
        • Ospedale Bellaria
      • Brindisi, Italy
        • Ospedale Senatore Antonio Perrino
      • Catania, Italy
        • A.O. Garibaldi Nesimadi Catania
      • Faenza, Italy
        • Ospedale Civile di Faenza
      • Ferrara, Italy
        • A.O.U. Arcispedale Sant'Anna di Ferrara
      • Frosinone, Italy
        • Ospedale Fabrizio Spaziani della ASL di Frosinone
      • Lugo, Italy
        • Ospedale Umbero I
      • Milano, Italy
        • Istituto Nazionale Tumori
      • Modena, Italy
        • A.O. Univeristaria Policlinico
      • Napoli, Italy, 80131
        • Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
      • Napoli, Italy
        • Seconda Universita di Napoli
      • Perugia, Italy
        • Ospedale Silvestrini
      • Ravenna, Italy
        • Ospedale S. Maria delle Croci AUSL di Ravenna
      • Reggio Calabria, Italy
        • A.O. Bainchi Melacrino Morelli Osp. Riuniti
      • Rimini, Italy
        • Ospedale degli Infermi, P.O. Ospedale Civile
      • Roma, Italy
        • Policlinico Umberto I
      • Roma, Italy
        • Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Cytologic / histologic diagnosis of stage IC-IV ovarian cancer
  • Disease progressed during first line chemotherapy or disease relapsed within 6 months after the last platinum treatment
  • Disease evaluable by RECIST or Ca 125 GCIG criteria
  • No residual peripheral neurotoxicity from previous chemotherapy treatment
  • PS 0-1
  • Aged at least 18 and not greater than 75 years.
  • Life expectancy of at least 3 months
  • Able to swallow and retain oral medication
  • Written informed consent prior to performance of study specific procedures or assessments
  • Ability and willingness to comply with treatment and follow up assessments and procedures

Exclusion Criteria:

· • Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)

  • Previous treatment with weekly paclitaxel
  • More than 2 previous chemotherapy treatments
  • Serious heart disease, including heart failure, atrioventricular block of any degree, serious arrhythmia or history of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, coronary artery by-pass graft surgery, class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA)
  • Hemoglobin < 9 g/dL, neutrophils < 1500/mm3, platelets < 100000/mm3
  • Impairment of renal function (patients should have 2 functioning kidneys): creatinine 1.5 times the upper normal limit - UNL; calculated creatinine clearance < 50 mL/min; urine protein to creatinine ratio > or = 1: then, a 24-hour urine protein must be assessed and subject must have a 24-hour urine protein value <1gr to be eligible
  • Impairment of liver function (SGOT or SGPT > or = 2.5 UNL, alkaline phosphatase > 2.5 ULN, total bilirubin > 1.5 times the UNL)
  • Prothrombin time (PT) or international normalized ratio (INR) or activated partial thromboplastin time (PTT) > 1.2 times the UNL
  • Pregnancy, breast feeding, or inadequate contraception
  • Unable to discontinue prohibited medications (see protocol section 6.7)
  • Clinically significant gastrointestinal abnormalities which might interfere with oral dosing, including but not limited to malabsorption syndrome, major resection of the stomach or small bowel that could affect drug absorption, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment, signs or symptoms of GI obstruction
  • Any unstable or serious concurrent condition
  • Prolongation of corrected QT interval (QTc) >480 ms
  • History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
  • Macroscopic hematuria
  • Major surgery or trauma within 30 days
  • Hypertension uncontrolled with adequate therapy (systolic blood pressure (BP) of > or = 140mmHg, or diastolic BP of > or = 90mmHg)
  • Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity
  • Present or suspected haemorrhagic syndromes
  • Patients' inability to access the centre due to area of residence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: paclitaxel and pazopanib
Drug: paclitaxel
80 mg/m2 IV days 1, 8, 15 every 28 days
Drug: pazopanib
orally, 800 mg orally daily
ACTIVE_COMPARATOR: paclitaxel
Drug: paclitaxel
80 mg/m2 IV days 1, 8, 15 every 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: 6 months from randomization
6 months from randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
number of patients with objective response
Time Frame: at 2 months and 4 months after randomization
at 2 months and 4 months after randomization
worst grade toxicity per patient
Time Frame: at end of each 28 day cycle of therapy
at end of each 28 day cycle of therapy
overall survival
Time Frame: one year from randomization
one year from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2010

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

December 29, 2015

Study Registration Dates

First Submitted

July 17, 2012

First Submitted That Met QC Criteria

July 17, 2012

First Posted (ESTIMATE)

July 19, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 9, 2018

Last Update Submitted That Met QC Criteria

April 6, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MITO-11
  • 2009-016151-21 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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