Bevacizumab and Carboplatin for Patients With Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Vejle Hospital
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT00744718
First received: August 29, 2008
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Ovarian Cancer
Drug: Bevacizumab
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bevacizumab and Carboplatin for Patients With Platin Resistant Epithelial Ovarian Cancer. A Phase II Study.

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: From date of first treatment until date of verified progression or death. 12 months of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: From date of first treatment until death. Up to 12 months ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: Every 9 weeks until progression or death. Up to 12 months ] [ Designated as safety issue: No ]
  • Response duration [ Time Frame: From date of first documented response until date of progression. Up to 12 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bevacizumab
    Bevacizumab 10 mg/kg every 3 weeks
    Drug: Carboplatin
    Carboplatin AUC 5 every 5 weeks
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744718

Contacts
Contact: Anders Jakobsen, MD, DMSc +45 7940 6010 anders.jakobsen@rsyd.dk
Contact: Jette Leonhardt, Study Nurse +45 7940 4554 jette.leonhardt@rsyd.dk

Locations
Denmark
Vejle Hospital Recruiting
Vejle, Denmark, DK-7100
Principal Investigator: Maja P Smerdel, MD         
Sponsors and Collaborators
Vejle Hospital
  More Information

No publications provided

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT00744718     History of Changes
Other Study ID Numbers: 2008-000878-20, S-20080033, 2612-3754
Study First Received: August 29, 2008
Last Updated: March 28, 2014
Health Authority: Denmark: National Board of Health

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Bevacizumab
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014