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

Phase 2
18 Years
75 Years
Open (Enrolling)
Ovarian Cancer

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Trial Information

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

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

- Ability and willingness to comply with treatment and follow up assessments and

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Time Frame:

6 months from randomization

Safety Issue:


Principal Investigator

Sandro Pignata, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute, Naples


Italy: Ethics Committee

Study ID:




Start Date:

December 2010

Completion Date:

December 2014

Related Keywords:

  • Ovarian Cancer
  • platinum resistant
  • platinum refractory
  • Ovarian Neoplasms