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

NCT ID: NCT01644825

Last Updated: 2018-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2015-12-29

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

paclitaxel and pazopanib

Group Type: EXPERIMENTAL

paclitaxel

Intervention Type: DRUG

80 mg/m2 IV days 1, 8, 15 every 28 days

pazopanib

Intervention Type: DRUG

orally, 800 mg orally daily

paclitaxel

Group Type: ACTIVE_COMPARATOR

paclitaxel

Intervention Type: DRUG

80 mg/m2 IV days 1, 8, 15 every 28 days

Interventions

paclitaxel

80 mg/m2 IV days 1, 8, 15 every 28 days

Intervention Type: DRUG

pazopanib

orally, 800 mg orally daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Naples

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Naples

Francesco Perrone, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Naples

Ciro Gallo, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Campania Luigi Vanvitelli

Locations

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

Milan, , 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, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 25882986 (View on PubMed)

Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

Reference Type: DERIVED

PMID: 37185961 (View on PubMed)

Other Identifiers

2009-016151-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MITO-11

Identifier Type: -

Identifier Source: org_study_id