Bevacizumab and Carboplatin for Patients With Ovarian Cancer

NCT00744718 | Completed Phase 2 DMC

• 3 other identifiers: 2008-000878-20S-200800332612-3754
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  From date of first treatment until date of verified progression or death. 12 months of follow-up

Secondary Outcomes (3)

• 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.

Interventions

Bevacizumab DRUG

Bevacizumab 10 mg/kg every 3 weeks

Carboplatin DRUG

Carboplatin AUC 5 every 5 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Vejle Hospital

Vejle, DK-7100, Denmark

Location

Related Publications (1)

• Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

  PMID: 37185961 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals

Study Officials

• Anders Jakobsen, MD, DMSc

  Department of Oncology, Vejle Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 16, 2016

Record last verified: 2016-11

Locations

DK (1)