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

NCT01644825 | Completed Phase 2

• 2 other identifiers: MITO-112009-016151-21
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 20

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

Keywords

platinum resistant; platinum refractory

Outcome Measures

Primary Outcomes (1)

• progression free survival

  6 months from randomization

Secondary Outcomes (3)

• number of patients with objective response

  at 2 months and 4 months after randomization

• worst grade toxicity per patient

  at end of each 28 day cycle of therapy

• overall survival

  one year from randomization

Study Arms (2)

paclitaxel and pazopanib

EXPERIMENTAL

Drug: paclitaxel; Drug: pazopanib

paclitaxel

ACTIVE COMPARATOR

Drug: paclitaxel

Interventions

paclitaxel DRUG

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

paclitaxel; paclitaxel and pazopanib

pazopanib DRUG

orally, 800 mg orally daily

paclitaxel and pazopanib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• · • 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

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (20)

Osp. Regionale Mulli

Acquaviva delle Fonti, Italy

Location

Ospedale San donato

Arezzo, Italy

Location

A.O. G. Rummo

Benevento, Italy

Location

Ospedale Bellaria

Bologna, Italy

Location

Ospedale Senatore Antonio Perrino

Brindisi, Italy

Location

A.O. Garibaldi Nesimadi Catania

Catania, Italy

Location

Ospedale Civile di Faenza

Faenza, Italy

Location

A.O.U. Arcispedale Sant'Anna di Ferrara

Ferrara, Italy

Location

Ospedale Fabrizio Spaziani della ASL di Frosinone

Frosinone, Italy

Location

Ospedale Umbero I

Lugo, Italy

Location

Istituto Nazionale Tumori

Milan, Italy

Location

A.O. Univeristaria Policlinico

Modena, Italy

Location

Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico

Napoli, 80131, Italy

Location

Seconda Universita di Napoli

Napoli, Italy

Location

Ospedale Silvestrini

Perugia, Italy

Location

Ospedale S. Maria delle Croci AUSL di Ravenna

Ravenna, Italy

Location

A.O. Bainchi Melacrino Morelli Osp. Riuniti

Reggio Calabria, Italy

Location

Ospedale degli Infermi, P.O. Ospedale Civile

Rimini, Italy

Location

Policlinico Umberto I

Roma, Italy

Location

Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore

Roma, Italy

Location

Related Publications (2)

• 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.

  PMID: 25882986 BACKGROUND

• 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.

  PMID: 37185961 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Paclitaxel; pazopanib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 19, 2012
• Study Start: December 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: December 29, 2015
• Last Updated: April 9, 2018

Record last verified: 2018-04

Locations

IT (20)