Bevacizumab and Carboplatin for Patients With Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00744718
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : November 16, 2016
Information provided by (Responsible Party):
Vejle Hospital

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Bevacizumab Drug: Carboplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bevacizumab and Carboplatin for Patients With Platin Resistant Epithelial Ovarian Cancer. A Phase II Study.
Study Start Date : August 2008
Actual Primary Completion Date : August 2015
Actual Study Completion Date : December 2015

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

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: From date of first treatment until date of verified progression or death. 12 months of follow-up ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From date of first treatment until death. Up to 12 months ]
  2. Response rate [ Time Frame: Every 9 weeks until progression or death. Up to 12 months ]
  3. Response duration [ Time Frame: From date of first documented response until date of progression. Up to 12 months. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00744718

Vejle Hospital
Vejle, Denmark, DK-7100
Sponsors and Collaborators
Vejle Hospital
Study Chair: Anders Jakobsen, MD, DMSc Department of Oncology, Vejle Hospital

Responsible Party: Vejle Hospital Identifier: NCT00744718     History of Changes
Other Study ID Numbers: 2008-000878-20
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents