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

Phase 2

Completed

Conditions: Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Objective Tumor Response	every other cycle for the first 6 months; then every 3 months thereafter (up to 5 years)	Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy6
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	Prior to each cycle and 30 days after the last cycle (average of 5 months)

Secondary Outcome Measures

Name	Time	Method
Duration of Progression-free Survival and Overall Survival	up to 5 years

Locations (37): Providence Saint Joseph Medical Center - Burbank
🇺🇸
Burbank, California, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸
Los Angeles, California, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
🇺🇸
New Britain, Connecticut, United States
Tunnell Cancer Center at Beebe Medical Center
🇺🇸
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
🇺🇸
Newark, Delaware, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸
Savannah, Georgia, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Hinsdale Hematology Oncology Associates
🇺🇸
Hinsdale, Illinois, United States
St. Vincent Indianapolis Hospital
🇺🇸
Indianapolis, Indiana, United States
Union Hospital Cancer Program at Union Hospital
🇺🇸
Elkton, Maryland, United States
Scroll for more (27 remaining)
Providence Saint Joseph Medical Center - Burbank
🇺🇸Burbank, California, United States