NCT00569673

Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer

A Phase II Evaluation of Docetaxel (NSC #628503) Plus Trabectedin (Yondelis®), R279741, IND # 101018) With Growth Factor Support in the Third-Line Treatment of Recurrent or Persistent Ovarian, Fallopian Tube or Primary Peritoneal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with G-CSF or pegfilgrastim may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving docetaxel and trabectedin together with G-CSF or pegfilgrastim works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

Detailed description

OBJECTIVES: Primary * To estimate the antitumor activity of docetaxel plus trabectedin in patients with persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer primarily through the frequency of objective tumor responses. * To determine the nature and degree of toxicity of docetaxel plus trabectedin in this cohort of patients. Secondary * To estimate the progression-free survival and overall survival of patients treated with docetaxel and trabectedin. OUTLINE: Patients receive docetaxel IV over 1 hour and trabectedin IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously (SC) on day 1 OR filgrastim (G-CSF) IV over 15-30 minutes or SC once daily beginning on day 1 and continuing until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
BIOLOGICAL	pegfilgrastim
DRUG	docetaxel
DRUG	trabectedin

Timeline

• Start date: 2008-03-01
• Primary completion: 2012-01-01
• First posted: 2007-12-07
• Last updated: 2018-07-18
• Results posted: 2014-06-26

Locations

37 sites across 1 country: United States