18 and older, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free SurvivalPrimary· Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)
Progression-free survival was defined as the time from the first administration of any study treatment to the first disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
Group
Value
95% CI
Bevacizumab + Paclitaxel + Carboplatin
23.7
19.9 – 26.4
Percentage of Participants With an Objective ResponseSecondary· Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)
An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), a CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions and a PR was defined as the disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal pr
RECIST only (N=91)
Group
Value
95% CI
Bevacizumab + Paclitaxel + Carboplatin
84.6
75.5 – 91.3
CA-125 level only (N=101)
Group
Value
95% CI
Bevacizumab + Paclitaxel + Carboplatin
97.0
91.6 – 99.4
RECIST and CA-125 level combined (N=126)
Group
Value
95% CI
Bevacizumab + Paclitaxel + Carboplatin
92.1
85.9 – 96.1
Duration of ResponseSecondary· Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)
Duration of response was defined as the interval between the date of the first documented response by RECIST to the date of first disease progression or death, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the
RECIST only (N=77)
Group
Value
95% CI
Bevacizumab + Paclitaxel + Carboplatin
14.7
12.7 – 16.1
CA-125 level only (N=98)
Group
Value
95% CI
Bevacizumab + Paclitaxel + Carboplatin
17.5
15.4 – 21.9
RECIST and CA-125 level combined (N=116)
Group
Value
95% CI
Bevacizumab + Paclitaxel + Carboplatin
17.4
15.4 – 21.9
Overall Survival at 1 Year and 2 YearsSecondary· Baseline to Year 2
Reported are the percentage of participants that were alive at 1 year and 2 years after enrolling in the study.
Year 1
Group
Value
95% CI
Bevacizumab + Paclitaxel + Carboplatin
97.7
95.4 – 99.9
Year 2
Group
Value
95% CI
Bevacizumab + Paclitaxel + Carboplatin
92.1
88.0 – 96.2
Biological Progression-free IntervalSecondary· Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)
Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for patients with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for patients with ele
Group
Value
95% CI
Bevacizumab + Paclitaxel + Carboplatin
NA
NA – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline to the end of the study (up to 4 years, 1 month).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07504588 — Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and
· Phase 2
· not yet recruiting
NCT07500298 — Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable
· Phase 1
· not yet recruiting
NCT07271355 — Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colore
· Phase 3
· not yet recruiting
NCT07318389 — ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer
· EARLY_PHASE1
· not yet recruiting
NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance
· Phase 2
· not yet recruiting
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Currently open trials in the same condition.
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· recruiting
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· recruiting
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· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 6 November 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00937560.