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A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer

NCT00937560

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Ovarian Cancer

Interventions: Bevacizumab, Paclitaxel, Carboplatin

Countries: Brazil, France, Italy, Netherlands, Norway, Russia, Spain, Sweden

This single arm study evaluated the efficacy and safety of first-line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants received 6-8 3-week cycles of treatment with bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m\^2 iv on days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve (AUC) of 6 on day 1 of each cycle. Following combination chemotherapy, bevacizumab could be continued to be given as a monotherapy.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria

* Female patients, ≥ 18 years of age.
* Epithelial ovarian, fallopian tube, or primary peritoneal cancer.
* Initial surgery, but no chemotherapy or radiotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Exclusion Criteria

* Non-epithelial tumors.
* Ovarian tumors with low malignant potential.
* Previous systemic anti-cancer therapy for ovarian cancer.
* History or evidence of synchronous primary endometrial cancer.
* Current or recent daily treatment with aspirin (\> 325mg/day) or with full dose anticoagulant or thrombolytic agents for therapeutic purposes.

Locations (55)

Jaú, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Avignon, France
Bordeaux, France
Bordeaux, France
Brive-la-Gaillarde, France
Clamart, France
Dijon, France
Gap, France
Grenoble, France
Marseille, France
Metz-Tessy, France
Nice, France
Paris, France
Paris, France
Poitiers, France
Saint-Priest-en-Jarez, France
Strasbourg, France
Toulouse, France
Vandœuvre-lès-Nancy, France
Naples, Campania, Italy
Modena, Emilia-Romagna, Italy
Rome, Lazio, Italy
Campobasso, Molise, Italy
Alkmaar, Netherlands
Amsterdam, Netherlands
Enschede, Netherlands
Groningen, Netherlands
Leidschendam, Netherlands
Tilburg, Netherlands
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