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Bevacizumab and Carboplatin for Patients With Ovarian Cancer

This study is currently recruiting participants.
Verified by Vejle Hospital, September 2008

Sponsored by: Vejle Hospital
Information provided by: Vejle Hospital
ClinicalTrials.gov Identifier: NCT00744718
  Purpose

In 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, carboplatin
Phase II

MedlinePlus related topics:   Cancer    Ovarian Cancer   

Drug Information available for:   Carboplatin    Bevacizumab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Bevacizumab and Carboplatin for Patients With Platin Resistant Epithelial Ovarian Cancer. A Phase II Study.

Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Progression free survival

Secondary Outcome Measures:
  • Overall survival
  • Response rate
  • Time to progression
  • Toxicity

Estimated Enrollment:   30
Study Start Date:   August 2008
Estimated Study Completion Date:   June 2011
Estimated Primary Completion Date:   January 2010 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: bevacizumab, carboplatin
    Bevacizumab 10 mg/kg every 3 weeks 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 incl. 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 anticoagulantia 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

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

Contacts
Contact: Anders Jakobsen, MD, DMSc     +45 7940 6010     anders.jakobsen@slb.regionsyddanmark.dk    
Contact: Gitte Moeller, Study Nurse     +45 7940 6709     gitte.eiberg.moeller@slb.regionsyddanmark.dk    

Locations
Denmark
Vejle Hospital     Recruiting
      Vejle, Denmark, DK-7100
      Principal Investigator: Maja P Smerdel, MD            

Sponsors and Collaborators
Vejle Hospital
  More Information


Responsible Party:   Vejle Hospital ( Anders Jakobsen, Professor, MD, DMSc )
Study ID Numbers:   2008-000878-20, S-20080033, 2612-3754
First Received:   August 29, 2008
Last Updated:   September 2, 2008
ClinicalTrials.gov Identifier:   NCT00744718
Health Authority:   Denmark: National Board of Health

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Bevacizumab
Carboplatin
Ovarian epithelial cancer
Genital Diseases, Female
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on October 24, 2008




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