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Weekly Paclitaxel With or Without Pazopanib in Platinum Resistant or Refractory Ovarian Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Weekly Paclitaxel With or Without Pazopanib in Platinum Resistant or Refractory Ovarian Cancer

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

NCT01644825•National Cancer Institute, Naples

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

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)
+10 more criteria

Locations (20)

Osp. Regionale Mulli

Acquaviva delle Fonti, Italy

Ospedale San donato

Arezzo, Italy

A.O. G. Rummo

Benevento, Italy

Ospedale Bellaria

Bologna, Italy

Ospedale Senatore Antonio Perrino

Brindisi, Italy

A.O. Garibaldi Nesimadi Catania

Catania, Italy

Ospedale Civile di Faenza

Faenza, Italy

A.O.U. Arcispedale Sant'Anna di Ferrara

Ferrara, Italy

Ospedale Fabrizio Spaziani della ASL di Frosinone

Frosinone, Italy

Ospedale Umbero I

Lugo, Italy

Key Dates

Start Date

December 1, 2010

Primary Completion Date

May 1, 2014

Completion Date

December 29, 2015

Last Updated

April 9, 2018

Enrollment

ESTIMATED participants

Conditions

Ovarian Cancer

Interventions

paclitaxel

DRUG

pazopanib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 9, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Weekly Paclitaxel With or Without Pazopanib in Platinum Resistant or Refractory Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

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