Weekly Paclitaxel With or Without Pazopanib in Platinum Resistant or Refractory Ovarian Cancer (MITO-11)
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| ClinicalTrials.gov Identifier: NCT01644825 |
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Recruitment Status :
Completed
First Posted : July 19, 2012
Last Update Posted : April 9, 2018
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Sponsor:
National Cancer Institute, Naples
Information provided by (Responsible Party):
National Cancer Institute, Naples
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ovarian Cancer | Drug: paclitaxel Drug: pazopanib | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 72 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | December 2010 |
| Actual Primary Completion Date : | May 2014 |
| Actual Study Completion Date : | December 29, 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ovarian cancer
MedlinePlus related topics:
Ovarian Cancer
| 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 |
Primary Outcome Measures :
- progression free survival [ Time Frame: 6 months from randomization ]
Secondary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644825
Locations
Show 20 study locations
Sponsors and Collaborators
National Cancer Institute, Naples
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" |
Publications:
| Responsible Party: | National Cancer Institute, Naples |
| ClinicalTrials.gov Identifier: | NCT01644825 |
| Other Study ID Numbers: |
MITO-11 2009-016151-21 ( EudraCT Number ) |
| First Posted: | July 19, 2012 Key Record Dates |
| Last Update Posted: | April 9, 2018 |
| Last Verified: | April 2018 |
Keywords provided by National Cancer Institute, Naples:
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platinum resistant platinum refractory |
Additional relevant MeSH terms:
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms |
Genital Diseases Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |