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

• ClinicalTrials.gov Identifier: NCT01644825
• Recruitment Status: Completed
• First Posted: July 19, 2012
• Last Update Posted: April 9, 2018
• Sponsor: National Cancer Institute, Naples
• Information provided by (Responsible Party): National Cancer Institute, Naples

Tracking Information

• First Submitted Date: July 17, 2012
• First Posted Date: July 19, 2012
• Last Update Posted Date: April 9, 2018
• Actual Study Start Date: December 2010
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 17, 2012): progression free survival [ Time Frame: 6 months from randomization ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 17, 2012)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Weekly Paclitaxel With or Without Pazopanib in Platinum Resistant or Refractory Ovarian Cancer
• 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
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ovarian Cancer

Intervention

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

Study Arms

• Experimental: paclitaxel and pazopanib
  Interventions:

  • Drug: paclitaxel
  • Drug: pazopanib
• Active Comparator: paclitaxel
  Intervention: Drug: paclitaxel

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: July 17, 2012): 72
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 29, 2015
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT01644825
• Other Study ID Numbers: MITO-11; 2009-016151-21 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: National Cancer Institute, Naples
• Original Responsible Party: Same as current
• Current Study Sponsor: National Cancer Institute, Naples
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sandro Pignata, M.D., Ph.D.; National Cancer Institute, Naples
• Principal Investigator: Francesco Perrone, M.D., Ph.D.; National Cancer Institute, Naples
• Principal Investigator: Ciro Gallo, M.D., Ph.D.; University of Campania "Luigi Vanvitelli"

• PRS Account: National Cancer Institute, Naples
• Verification Date: April 2018