Bevacizumab and Carboplatin for Patients With Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00744718
• Other study ID #: 2008-000878-20
• Secondary ID: S-200800332612-3
• Status: Completed
• Phase: Phase 2
• First received: August 29, 2008
• Last updated: November 15, 2016
• Start date: August 2008
• Est. completion date: December 2015

Study information

• Verified date: November 2016
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Bevacizumab
Bevacizumab 10 mg/kg every 3 weeks
• Carboplatin
Carboplatin AUC 5 every 5 weeks

Locations

Country	Name	City	State
Denmark	Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		From date of first treatment until date of verified progression or death. 12 months of follow-up	No
Secondary	Overall survival		From date of first treatment until death. Up to 12 months	No
Secondary	Response rate		Every 9 weeks until progression or death. Up to 12 months	No
Secondary	Response duration		From date of first documented response until date of progression. Up to 12 months.	No