Clinical trial · Interventional
A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer
Global Study to Assess the Addition of Bevacizumab to Carboplatin and Paclitaxel as Front-line Treatment of Epithelial Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in participants with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Participants will receive 15 milligrams/kilogram (mg/kg) Avastin intravenously (IV) on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (area under the plasma concentration-time curve \[AUC\] 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of 8 cycles and paclitaxel 175 milligram per square meter (mg/m\^2) on Day 1 every 3 weeks or 80 mg/m\^2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108 weeks or until disease progression or unacceptable toxicity.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab + Paclitaxel + Carboplatin
- description
- Participants will receive bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol defined disease progression or until unacceptable toxicity (whichever occurred first). Participants will receive paclitaxel 175 mg/m\^2 IV on Day 1 every 3 weeks or 80 mg/m\^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol defined disease progression, or unacceptable toxicity (whichever occurred first).
- interventionNames
- Drug: Paclitaxel
- Drug: Bevacizumab
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Percentage of Participants With at Least One Adverse Event (AE)
- timeFrame
- Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years)
- description
- An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma or clear cell carcinoma or carcinosarcoma. Participants 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 greater than or equal to (\>=3) months Exclusion Criteria: * Participants 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 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade \>=1 arterial thromboembolic event or Grade \>=3 venous thromboembolic event within 6 months prior to enrollment
References
Publications (1)
- DERIVEDOza AM, Selle F, Davidenko I, Korach J, Mendiola C, Pautier P, Chmielowska E, Bamias A, DeCensi A, Zvirbule Z, Gonzalez-Martin A, Hegg R, Joly F, Zamagni C, Gadducci A, Martin N, Robb S, Colombo N. Efficacy and Safety of Bevacizumab-Containing Therapy in Newly Diagnosed Ovarian Cancer: ROSiA Single-Arm Phase 3B Study. Int J Gynecol Cancer. 2017 Jan;27(1):50-58. doi: 10.1097/IGC.0000000000000836. PMID 27749456