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

Ovarian Cancer Clinical Trial

— MITO-11  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644825
• Other study ID #: MITO-11
• Secondary ID: 2009-016151-21
• Status: Completed
• Phase: Phase 2
• First received: July 17, 2012
• Last updated: April 6, 2018
• Start date: December 2010
• Est. completion date: December 29, 2015

Study information

• Verified date: April 2018
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 29, 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• paclitaxel
80 mg/m2 IV days 1, 8, 15 every 28 days
• pazopanib
orally, 800 mg orally daily

Locations

Country	Name	City	State
Italy	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	Istituto Nazionale Tumori	Milano
Italy	A.O. Univeristaria Policlinico	Modena
Italy	Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico	Napoli
Italy	Seconda Universita di Napoli	Napoli
Italy	Ospedale Silvestrini	Perugia
Italy	Ospedale S. Maria delle Croci AUSL di Ravenna	Ravenna
Italy	A.O. Bainchi Melacrino Morelli Osp. Riuniti	Reggio Calabria
Italy	Ospedale degli Infermi, P.O. Ospedale Civile	Rimini
Italy	Policlinico Umberto I	Roma
Italy	Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore	Roma

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Pignata S, Lorusso D, Scambia G, Sambataro D, Tamberi S, Cinieri S, Mosconi AM, Orditura M, Brandes AA, Arcangeli V, Panici PB, Pisano C, Cecere SC, Di Napoli M, Raspagliesi F, Maltese G, Salutari V, Ricci C, Daniele G, Piccirillo MC, Di Maio M, Gallo C, Perrone F; MITO 11 investigators. Pazopanib plus weekly paclitaxel versus weekly paclitaxel alone for platinum-resistant or platinum-refractory advanced ovarian cancer (MITO 11): a randomised, open-label, phase 2 trial. Lancet Oncol. 2015 May;16(5):561-8. doi: 10.1016/S1470-2045(15)70115-4. Epub 2015 Apr 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		6 months from randomization
Secondary	number of patients with objective response		at 2 months and 4 months after randomization
Secondary	worst grade toxicity per patient		at end of each 28 day cycle of therapy
Secondary	overall survival		one year from randomization