Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
30

Summary

Conditions
  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube Carcinoma
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Ovarian Transitional Cell Carcinoma
  • Malignant Ovarian Brenner Tumor
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Undifferentiated Carcinoma
  • FIGO Stage IIIA1(ii) Ovarian Cancer
  • FIGO Stage IVB Ovarian Cancer
  • Fallopian Tube Mucinous Adenocarcinoma
  • Ovarian Clear Cell Adenocarcinoma
  • Fallopian Tube Serous Adenocarcinoma
  • FIGO Stage IIIA2 Ovarian Cancer
  • Fallopian Tube Transitional Cell Carcinoma
  • Ovarian Seromucinous Carcinoma
  • Ovarian Serous Adenocarcinoma
  • FIGO Stage IVA Ovarian Cancer
  • Primary Peritoneal Serous Adenocarcinoma
  • Fallopian Tube Undifferentiated Carcinoma
  • FIGO Stage III Ovarian Cancer
  • Ovarian Mucinous Adenocarcinoma
  • FIGO Stage IIIB Ovarian Cancer
  • FIGO Stage IIIA Ovarian Cancer
  • Primary Peritoneal Carcinoma
  • FIGO Stage IIIC Ovarian Cancer
  • FIGO Stage IIIA1 Ovarian Cancer
  • FIGO Stage IIIA1(i) Ovarian Cancer
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

PRIMARY OBJECTIVES: I. To determine whether patients with newly diagnosed ovarian, primary peritoneal, and fallopian tube cancers when treated with bevacizumab, carboplatin, and weekly paclitaxel can tolerate at least 4 cycles of therapy regardless of delay or dose modification. SECONDARY OBJECTIVES...

PRIMARY OBJECTIVES: I. To determine whether patients with newly diagnosed ovarian, primary peritoneal, and fallopian tube cancers when treated with bevacizumab, carboplatin, and weekly paclitaxel can tolerate at least 4 cycles of therapy regardless of delay or dose modification. SECONDARY OBJECTIVES: I. To estimate the efficacy of bevacizumab combined with carboplatin and weekly paclitaxel in patients with newly diagnosed ovarian, primary peritoneal, and fallopian tube cancers, as measured by progression-free survival. II. To evaluate the response rate in patients with newly diagnosed ovarian, primary peritoneal, and fallopian tube cancers when treated with bevacizumab, carboplatin, and weekly paclitaxel. TRANSLATIONAL RESEARCH OBJECTIVES: I. To assess the predictive value of a set of angiogenic genes whose expression correlates with progression-free survival of patients with epithelial ovarian, peritoneal primary or fallopian tube cancer treated with bevacizumab, carboplatin, and weekly paclitaxel. II. To assess the relationship among cytokines/chemokines, angiogenesis factors, novel targets of interest and clinical outcome including tumor response and progression-free survival in patients treated with bevacizumab, carboplatin, and weekly paclitaxel. OUTLINE: Participants receive paclitaxel intravenously (IV) over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up every 3 months for 2 years.

Tracking Information

NCT #
NCT01097746
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Anil Sood M.D. Anderson Cancer Center