Clinical Trial Investigating Pazopanib in Patients With Platinum-resistant Advanced Ovarian Cancer

NCT01262014 | Completed Phase 2

• 2 other identifiers: GEICO-10022010-020439-38
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 20

Brief Summary

Given the low Responses Rates and short survival times achieved with conventional cytotoxic agents in resistant ovarian cancer patients, new treatment options are needed in this patient population.Antiangiogenic therapy has an important role in this group of patients and Pazopanib in particular. We are going to study if Pazopanib is able to control disease-related symptoms minimizing the side effects of treatment. This aspect is very important in the treatment of resistant ovarian cancer patient since our treatment is palliative without any impact in overall survival. So our goal is to study the Clinical Benefit Rate (objective responses plus stable disease rates) achieved with Pazopanib and its toxicity profile in this subgroup of patients

Conditions

Platinum-resistant Advanced Ovarian Cancer

Keywords

platinum; resistant; advanced; ovarian; cancer

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint for this study is Clinical Benefit Rate

  Clinical Benefit Rate defined as the percentage of patients with Complete Response plus Partial Response plus Stable Disease ≥ 8 weeks by RECIST v1.1

  average 30 months

Secondary Outcomes (7)

• Progression Free Survival (PFS)

  average 30 months

• Biological Response by CA-125 (GCIG Criteria)

  average 30 months

• Overall Survival (OS)

  Average 3 years

• Biological progression-free interval (PFIBIO)

  average 30 months

• Quality of Life and symptom control

  average 5 years

Study Arms (1)

Experimental single arm

EXPERIMENTAL

Single arm of pazopanib 800 mg (2x400mg) given as a single agent.

Drug: Pazopanib

Interventions

Pazopanib DRUG

800 mg (2x400mg) pazopanib per day should be taken orally without food at least one hour before or two hours after a meal until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent by the patient, or investigator decision.

Experimental single arm

Eligibility Criteria

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

You may qualify if:

• Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up.
• Age ≥ 18 years
• The patient has histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• The patient has completed at least 4 CYCLES OF one and up to two platinum-containing regimens (involving cisplatin or carboplatin),for the management of this condition. Treatment may have included intraperitoneal therapy, consolidation or extended therapy administered after surgical or nonsurgical assessment.
• The patient must have a platinum-free interval of ≤ 6 months after the final dose of primary or subsequent platinum-based therapy.
• Patients must have platinum-resistant disease,(defined as progression within \<6 months from completion of a minimum of 4 platinum therapy cycles. The date should be calculated from the last administered dose of platinum therapy.
• The patient has at least one unidimensionally measurable target lesion (≥ 20 mm or ≥ 10 mm by spiral computed tomography \[CT\] or magnetic resonance imaging \[MRI\]), as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines V 1.1.
• Previously archived tumor tissue from either the primary or metastatic tumor (paraffin block or 10 unstained slides) should be collected prior to administration of the first dose of study therapy and stored at a secure central laboratory.
• Adequate organ system function
• Women of child bearing potential should be using an effective method of contraception (complete abstinence, any intrauterine device (IUD) with published data showing that the lowest expected failure rate is \< 1 % per year; or any other methods with published data showing that the lowest expected failure rate is less than 1 % per year) before entry into the study and throughout the same and for 6 months after ending the study. Women of childbearing potential must have a negative test serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta human chorionic gonadotropin \[β-HCG\]) within 7 days prior to randomization.
• Able to swallow oral compound.
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.

You may not qualify if:

• Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
• Previous treatment with \>2 anticancer regimens for ovarian cancer
• Prior treatment with any antiangiogenic treatment (i.e. Bevacizumab)
• Patients with platinum-refractory disease defined as those patients progress during platinum-based therapy.
• History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) is required only if clinically indicated or if the subject has a history of CNS metastases.
• Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
• Active peptic ulcer disease
• Known intraluminal metastatic lesion/s with risk of bleeding
• Inflammatory bowel disease (e.g. ulcerative colitis, Chrohn's disease), or other gastrointestinal conditions with increased risk of perforation
• History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment.
• active episodes of intestinal pseudo-obstruction
• Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
• Malabsorption syndrome
• Major resection of the stomach or small bowel.
• Grade 3 diarrhoea

Sponsors & Collaborators

• Grupo Español de Investigación en Cáncer de Ovario: lead

Study Sites (20)

H. Alcorcón

Alcorcón, 28922, Spain

Location

H. de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

H Vall d'Hebron

Barcelona, 08035, Spain

Location

H. Clínic Barcelona

Barcelona, 08036, Spain

Location

H Reina Sofía Cordoba

Córdoba, 14004, Spain

Location

Intitut Català d' Oncolgia L' Hospitalet

L'Hospitalet de Llobregat, 08907, Spain

Location

HGU Gregorio Marañón

Madrid, 28007, Spain

Location

Centro Oncológico MD Anderson Spain

Madrid, 28034, Spain

Location

H Ramón y Cajal de Madrid

Madrid, 28034, Spain

Location

H Madrid. Centro Integral Oncológico Clara Campal

Madrid, 28250, Spain

Location

H de Sant Joan de Deu

Manresa, 08009, Spain

Location

H Morales Meseguer

Murcia, 30008, Spain

Location

H Son Dureta

Palma de Mallorca, 07003, Spain

Location

H Son Llatzer

Palma de Mallorca, 07003, Spain

Location

H. Parc Taulí

Sabadell, 08208, Spain

Location

H Marqués de Valdecilla

Santander, 39008, Spain

Location

H La Fe de Valencia

Valencia, 46009, Spain

Location

Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

H General de Valencia

Valencia, 46014, Spain

Location

H Miguel Servet

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Neoplasms

Interventions

pazopanib

Study Officials

• Ana Oaknin, MD

  H Vall d'Hebron

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: December 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: December 1, 2015
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

ES (20)