Zie pagina 39-40 van het protocol MO22923 versie 2, 26 Mei 2011
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Ovarian and fallopian tube disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Zie pagina 39 van het protocol MO22923 versie 2, 26 Mei 2011
Secondary outcome
Zie pagina 39 van het protocol MO22923 versie 2, 26 Mei 2011
Background summary
Zie pagina 31-39 van het protocol MO22923 versie 2, 26 Mei 2011
Study objective
Zie pagina 39-40 van het protocol MO22923 versie 2, 26 Mei 2011
Study design
Zie pagina 40-43 van het protocol MO22923 versie 2, 26 Mei 2011
Intervention
Zie pagina 50-61 en tabel 1 van het protocol MO22923 versie 2, 26 Mei 2011
Study burden and risks
The following assessments will be done: Intravenous administration of study
medication, physical examination, heart rate and blood pressure measurement,
blood and urine tests, pregnancy (if applicable), ECG, CT scans. There is a
risk of unknown side effects. Drawing blood samples may cause bruising (black
and blue marks) and discomfort where the blood was taken. There is also a
possibility of infection or blood clots at the site where the blood was taken.
There is a potential risk of radiation exposure from CT scans; however, this
risk is considered small. Chemotherapy can possible lead to nausea or vomiting,
leucocytopenia, thrombocytopenia, fatigue, allergic reactions (to paclitaxel),
hair loss, joint pain, muscle pain, damage to nerves of blood vessels, causing
mood swings, mouth ulcers, pigmentation and cause thrombosis. Bevacizumab can
lead to hypertension, numbness, or loss of sensation in the fingers or toes,
leucotytopenia, possible accompanied by fever, thrombocytopenia, shortness of
breath, diarrhea, rectal bleeding, nausea and vomiting, pain (including
headaches and joint pain), constipation inflammation of mucous membranes or
mouth inflammation, protein in urine, bleeding from mucous membranes (such as
nasal bleeding), lack of energy, weakness, loss of appetite, fever, runny nose,
dry skin, scaling and inflammation of the skin, change in the color of the
skin, change in taste perception and problems with eyes.
Beneluxlaan 2a
Woerden 3446 GR
NL
Beneluxlaan 2a
Woerden 3446 GR
NL
Listed location countries
Age
Inclusion criteria
- Female patients, >/=18 years of age;- Histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma or clear cell carcinoma or carcinosarcoma. Patients with recurrent ovarian cancer who have been previously treated with surgery alone for their early stage disease are eligible.;- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2;- Life expectancy >/=3 months
Exclusion criteria
- Patients with non-epithelial ovarian cancer, ovarian tumors with low malignant potential (i.e. borderline tumors), or synchronous primary endometrial carcinoma;- Previous systemic therapy for ovarian cancer. Prior neo-adjuvant chemotherapy is allowed;- Planned intraperitoneal cytotoxic chemotherapy;- Radiotherapy within 28 days of Day 1, Cycle 1;- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first dose of Avastin;- History or evidence of NCI CTCAE Grade >=1 arterial thromboembolic event or Grade >=3 venous thromboembolic event within the 6 months prior to enrolment
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-019525-34-NL |
| CCMO | NL33812.094.10 |