Ovarian Cancer Clinical Trial
Official title:
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
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.
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.
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