Bevacizumab and Carboplatin for Patients With Ovarian Cancer

Bevacizumab and Carboplatin for Patients With Platin Resistant Epithelial Ovarian Cancer. A Phase II Study.

This is a phase II trial to investigate the effect of bevacizumab and carboplatin in patients with platin resistant ovarian cancer.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: Bevacizumab; Drug: Carboplatin

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

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:

1. Histologically verified epithelial ovarian cancer, primary tubae- or primary peritoneal cancer (Stage I-IV)
2. Carboplatin resistant ovarian cancer previously treated with a maximum of three different cytostatic regimens (single substance or in combination).
3. Age ≥ 18 years.
4. Performance status 0-2.
5. Measurable disease according to CA125 GCIG criteria (Gynaecologic Cancer Intergroup) or RECIST (Response Evaluation Criteria in Solid Tumors) (See appendix I+II)
6. Adequate bonemarrow, liver and kidney function and coagulation parameters (within seven days of start of treatment).
7. ANC ≥ 1.5*109
8. Thrombocytes ≥ 100*10^9/L
9. Haemoglobin (Hb) ≥ 6 mmol/l
10. Se-bilirubin (BR) ≤ 1.5*ULN (Upper Limit of Normal)
11. Se-transaminase ≤ 2.5*ULN
12. Se-creatinin ≤ 1.5*ULN
13. 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.)
14. INR ≤1.5
15. APTT ≤ 1.5*ULN
16. Signed informed consent form.

Exclusion Criteria:

1. Patients who have received other types of experimental treatment or participated in a clinical study less than 28 days prior to this study.
2. Pregnant or breastfeeding women. A negative pregnancy test is mandatory for fertile women.
3. 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).
4. Untreated bowel obstruction or massive gastrointestinal tumors verified by CT scan.
5. Other present or previous malignant disease apart from curatively treated non-melanoma skin cancer or other types of cancer with minimal risk of relapse.
6. CNS-metastases.
7. Underlying medical disease not adequately treated (diabetes, cardiovascular disease).
8. Uncontrolled hypertension (persistent BP > 150/100 despite antihypertensive treatment).
9. Surgery incl. open biopsy less than 4 weeks before expected first dose of Bevacizumab.
10. Patients with non-healing wounds or fractures.
11. Previous cerebrovascular attack (TVA), transient ischaemic attack (TIA) or subarachnoidal bleeding (SAH) within last six months.
12. Thromboembolic or haemorrhagic disease in the anamnesis.

13. 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.
14. Present or previous chronical use of Aspirin (less than 10 days before start of treatment) Aspirin > 325 mg daily.
15. Present or recent use of full dose oral or parenteral anticoagulant or thrombolytic medicine.
16. Preexisting neuropathy, sensoric or motoric ≥ grade 2.
17. Decreased hearing.
18. Bleeding tumor.
19. Hypersensitivity to the active substance or one or more of the other substances contained in the protocol drugs.
20. Hypersensitivity to products from ovarian cells (CHO) from Chinese hamster or other recombinant or humanized antibodies.

Study Plan

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	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	From date of first treatment until death. Up to 12 months
Response rate	Every 9 weeks until progression or death. Up to 12 months
Response duration	From date of first documented response until date of progression. Up to 12 months.

Collaborators and Investigators

• Sponsor: Vejle Hospital

Study record dates

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: August 29, 2008
• First Posted (ESTIMATE): September 1, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): November 16, 2016
• Last Update Submitted That Met QC Criteria: November 15, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Carboplatin; Bevacizumab
• Other Study ID Numbers: 2008-000878-20; S-20080033; 2612-3754