Bevacizumab and Carboplatin in Ovarian Cancer - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Ovarian Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - Vejle, Denmark, DK-7100
    - Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Histologically verified epithelial ovarian cancer, primary tubae- or primary peritoneal cancer (Stage I-IV)
Carboplatin resistant ovarian cancer previously treated with a maximum of three different cytostatic regimens (single substance or in combination).
Age ≥ 18 years.
Performance status 0-2.
Measurable disease according to CA125 GCIG criteria (Gynaecologic Cancer Intergroup) or RECIST (Response Evaluation Criteria in Solid Tumors) (See appendix I+II)
Adequate bonemarrow, liver and kidney function and coagulation parameters (within seven days of start of treatment).
ANC ≥ 1.5*109
Thrombocytes ≥ 100*10^9/L
Haemoglobin (Hb) ≥ 6 mmol/l
Se-bilirubin (BR) ≤ 1.5*ULN (Upper Limit of Normal)
Se-transaminase ≤ 2.5*ULN
Se-creatinin ≤ 1.5*ULN
Urin stix for protein <2+ (If stix shows protein ≥2+ urin must be measured 24 hours where the protein content must be under 1 g.)
INR ≤1.5
APTT ≤ 1.5*ULN
Signed informed consent form.

Exclusion Criteria:

Patients who have received other types of experimental treatment or participated in a clinical study less than 28 days prior to this study.
Pregnant or breastfeeding women. A negative pregnancy test is mandatory for fertile women.
Fertile women, who do not wish to use safe contraception (e.g., birth control pills, coil, gestagen deposit injection, subdermal implantation, hormonal vagina ring, and transdermal deposit band-aid).
Untreated bowel obstruction or massive gastrointestinal tumors verified by CT scan.
Other present or previous malignant disease apart from curatively treated non-melanoma skin cancer or other types of cancer with minimal risk of relapse.
CNS-metastases.
Underlying medical disease not adequately treated (diabetes, cardiovascular disease).
Uncontrolled hypertension (persistent BP > 150/100 despite antihypertensive treatment).
Surgery incl. open biopsy less than 4 weeks before expected first dose of Bevacizumab.
Patients with non-healing wounds or fractures.
Previous cerebrovascular attack (TVA), transient ischaemic attack (TIA) or subarachnoidal bleeding (SAH) within last six months.
Thromboembolic or haemorrhagic disease in the anamnesis.
Clinically significant cardiovascular disease including Myocardial infarction or unstable angina less than 6 months prior to treatment
- New York heart Association NYHA class ≥ 2
- Poorly controlled cardial arrythmia despite medical treatment
- Peripheral vascular disease, grade 3 or above.
Present or previous chronical use of Aspirin (less than 10 days before start of treatment) Aspirin > 325 mg daily.
Present or recent use of full dose oral or parenteral anticoagulant or thrombolytic medicine.
Preexisting neuropathy, sensoric or motoric ≥ grade 2.
Decreased hearing.
Bleeding tumor.
Hypersensitivity to the active substance or one or more of the other substances contained in the protocol drugs.
Hypersensitivity to products from ovarian cells (CHO) from Chinese hamster or other recombinant or humanized antibodies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Interventional Model: FACTORIAL
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival Time Frame: From date of first treatment until date of verified progression or death. 12 months of follow-up	From date of first treatment until date of verified progression or death. 12 months of follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival Time Frame: From date of first treatment until death. Up to 12 months	From date of first treatment until death. Up to 12 months
Response rate Time Frame: Every 9 weeks until progression or death. Up to 12 months	Every 9 weeks until progression or death. Up to 12 months
Response duration Time Frame: From date of first documented response until date of progression. Up to 12 months.	From date of first documented response until date of progression. Up to 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

August 29, 2008

First Submitted That Met QC Criteria