Phase 2 N=45 Treatment

Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Ovarian Cancer · Fallopian Tube Cancer · Peritoneal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00267696 ↗

Enrolled (actual)

Serious AEs

8.9%

Results posted

Apr 2015

Primary outcome: 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 months

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Bevacizumab (Drug); Gemcitabine (Drug); Carboplatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Ohio State University Comprehensive Cancer Center
Primary completion: Sep 2013

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	—

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.

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

View full record on ClinicalTrials.gov →

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.