Ovarian CancerPhase 2NCT00744718
Bevacizumab and Carboplatin for Patients With Ovarian Cancer
A Phase 2 study testing Bevacizumab and Carboplatin in people with Ovarian Cancer, run by Vejle Hospital at 1 site in Denmark.
Trial summary
This is a phase II trial to investigate the effect of bevacizumab and carboplatin in patients with platin resistant ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Bevacizumab and Carboplatin
- How many people
- 73 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2008to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
- Signed informed consent form.
Who cannot join
- 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.
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- 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
- Peripheral vascular disease, grade 3 or above.
- Present or previous chronical use of Aspirin (less than 10 days before start of treatment) Aspirin > 325 mg daily.
- Present or recent use of full dose oral or parenteral anticoagulant or thrombolytic medicine.
- Preexisting neuropathy, sensoric or motoric ≥ grade 2.
- Decreased hearing.
- Bleeding tumor.
- Hypersensitivity to the active substance or one or more of the other substances contained in the protocol drugs.
- Hypersensitivity to products from ovarian cells (CHO) from Chinese hamster or other recombinant or humanized antibodies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bevacizumab and Carboplatin for Patients With Platin Resistant Epithelial Ovarian Cancer. A Phase II Study.
This is a phase II trial to investigate the effect of bevacizumab and carboplatin in patients with platin resistant ovarian cancer.
- Conditions
- Ovarian Cancer
- Being tested
- Bevacizumab, Carboplatin
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Bevacizumab 10 mg/kg every 3 weeks
CarboplatinDrug
Carboplatin AUC 5 every 5 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: From date of first treatment until date of verified progression or death. 12 months of follow-up
Secondary outcomes (3)
Overall survival
Measured: From date of first treatment until death. Up to 12 months
Response rate
Measured: Every 9 weeks until progression or death. Up to 12 months
Response duration
Measured: From date of first documented response until date of progression. Up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders Jakobsen, MD, DMSc, Study chair, Department of Oncology, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744718
- Sponsor's protocol ID
- 2008-000878-20
- Other IDs
- S-20080033, 2612-3754, 2008
- Status last verified
- Nov 2016
- First submitted
- 29 Aug 2008
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37185961
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab and Carboplatin for Patients With Platin Resistant Epithelial Ovarian Cancer. A Phase II Study.
- ClinicalTrials.gov ID
- NCT00744718
- Acronym / sponsor ID
- 2008-000878-20
- Conditions
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II trial to investigate the effect of bevacizumab and carboplatin in patients with platin resistant ovarian cancer.
Study design
- Primary purpose
- Treatment
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabBevacizumab 10 mg/kg every 3 weeks | Drug | – |
| CarboplatinCarboplatin AUC 5 every 5 weeks | Drug | – |
Primary outcome
Progression free survival
Time frame: From date of first treatment until date of verified progression or death. 12 months of follow-up
3 secondary outcomes
Overall survival
Time frame: From date of first treatment until death. Up to 12 months
Response rate
Time frame: Every 9 weeks until progression or death. Up to 12 months
Response duration
Time frame: From date of first documented response until date of progression. Up to 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Derived from this study: PubMed 37185961Gaitskell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Jakobsen, MD, DMSc study chair
Department of Oncology, Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab and Carboplatin in people with Ovarian Cancer, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: From date of first treatment until date of verified progression or death. 12 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00744718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2016.