Phase 2
Completed N=45
Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Ovarian Cancer · Fallopian tube cancer · Peritoneal Cancer
Source: ClinicalTrials.gov NCT00267696 ↗
Enrolled (actual)
45
Serious AEs
8.9%
Results posted
Apr 2015
Primary outcomePrimary: Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding. — 13.3 months
Summary
The purpose of this study is to test the effectiveness, safety and tolerability of the drug combination: gemcitabine, carboplatin and bevacizumab in patients that have been diagnosed with platinum sensitive recurrent ovarian cancer, fallopian tube or primary peritoneal cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding. |
13.3 | — |
| SECONDARY Overall Survival for Patients Treated With the Regimen. |
36.1 | — |
Eligibility Criteria
Inclusion Criteria
- Cancer of the ovaries, fallopian tube or abdominal lining has come back after more than 6 months from the last platinum based chemotherapy treatment.
- Disease must be detected by CT or CA125 level must be elevated or cancerous ascites must be present.
- History of at least one therapy of platinum based chemotherapy.
Exclusion Criteria
- Participation in another experimental drug study
- Heart disease or high blood pressure
- History of a stroke within the past 6 months
- Vascular disease, or bleeding problems
- Brain cancer
- Major Surgical Procedure within 28 days prior to start date
- Minor surgical procedures within 7 days prior to start date
- Pregnant or lactating
- Abdominal or bowel problems like bleeding
- History of abdominal fistula, GI perforation or Intra-abdominal abscess
- Serious, non-healing wound, ulcer or bone fracture
- Acute hepatitis
- Active infections requiring antibiotics
- Inability to comply with study or follow up procedures
Data sourced from ClinicalTrials.gov (NCT00267696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.