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

June 21, 2018 updated by: Gynecologic Oncology Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center - Burbank
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
    • Connecticut
      • New Britain, Connecticut, United States, 06050
        • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Tunnell Cancer Center at Beebe Medical Center
      • Newark, Delaware, United States, 19713
        • CCOP - Christiana Care Health Services
    • Georgia
      • Savannah, Georgia, United States, 31403-3089
        • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Hinsdale, Illinois, United States, 60521
        • Hinsdale Hematology Oncology Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Indianapolis Hospital
    • Maryland
      • Elkton, Maryland, United States, 21921
        • Union Hospital Cancer Program at Union Hospital
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMASS Memorial Cancer Center - University Campus
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
      • Springfield, Missouri, United States, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, United States, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-5636
        • University of New Mexico Cancer Center
    • North Carolina
      • Burlington, North Carolina, United States, 27216
        • Alamance Cancer Center at Alamance Regional Medical Center
      • Charlotte, North Carolina, United States, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, United States, 44106-5065
        • Case Comprehensive Cancer Center
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Cancer Care Center at MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Cancer Center at Fairview Hospital
      • Columbus, Ohio, United States, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health - West Hospital
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
      • Dayton, Ohio, United States, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Cancer Center at Hillcrest Hospital
      • Mentor, Ohio, United States, 44060
        • Lake/University Ireland Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Cancer Institute
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Rosenfeld Cancer Center at Abington Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • Abramson Cancer Center of The University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Cancer Center at Magee-Womens Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital of Rhode Island
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute at University of Utah
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Carilion Gynecologic Oncology Associates
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma

    • Recurrent or persistent disease
  • Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest dimension to be recorded) ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

  • Must have at least 1 "target lesion" to be used to assess response on this protocol as defined by RECIST criteria

    • Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy

  • Must have had 1 prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound and the initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment

    • Patients are allowed, but not required to receive, 2 additional cytotoxic regimens for management of recurrent or persistent disease with no more than 1 non-platinum, non-taxane regimen

    • Patients who have received only 1 prior cytotoxic regimen (platinum-based regimen for management of primary disease), must meet 1 of the following criteria:

      • Platinum-free interval of < 12 months
      • Progressed during platinum-based therapy
      • Persistent disease after a platinum-based therapy
  • Not eligible for a higher priority GOG protocol (i.e., any active GOG Phase III protocol for the same patient population)

PATIENT CHARACTERISTICS:

  • GOG performance status (PS) 0-2 or after receiving 1 prior treatment regimen (GOG PS 0-1 after receiving 2 or more prior regimens)
  • Platelet count ≥ 100,000/mm³
  • ANC count ≥ 1,500/mm³
  • Hemoglobin > 9 g/dL
  • Creatinine ≤ 1.5 times upper limit normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • CPK normal
  • Bilirubin or direct bilirubin normal
  • Alkaline phosphatase normal
  • Neuropathy (sensory and motor) ≤ grade 1
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring antibiotics (except for uncomplicated UTI)
  • No other invasive malignancy within the past 5 years, except nonmelanoma skin cancer
  • No known active liver disease or hepatitis
  • Willing and able to have a central venous catheter

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from effects of recent surgery, radiotherapy, or chemotherapy

  • At least 1 week since prior hormonal therapy directed at the malignant tumor

    • Continuation of hormone replacement therapy allowed
  • At least 3 weeks since other prior therapy, including biological and immunological therapy directed at the tumor
  • Chimeric or human or humanized monoclonal antibodies must be discontinued for at least 6 weeks prior to study entry
  • No investigational therapy within the past 30 days
  • No prior therapy with docetaxel and/or trabectedin
  • No radiation to more than 25% of marrow-bearing areas
  • No prior cancer treatment that contraindicates protocol therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Tumor Response
Time Frame: 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
every other cycle for the first 6 months; then every 3 months thereafter (up to 5 years)
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Time Frame: Prior to each cycle and 30 days after the last cycle (average of 5 months)
Prior to each cycle and 30 days after the last cycle (average of 5 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of Progression-free Survival and Overall Survival
Time Frame: up to 5 years
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Bradley J. Monk, MD, Chao Family Comprehensive Cancer Center
  • Kristine M. Zanotti, MD, MacDonald Physicians, Incorporated at University MacDonald Womens Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

December 6, 2007

First Submitted That Met QC Criteria

December 6, 2007

First Posted (Estimate)

December 7, 2007

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

June 21, 2018

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-0186F
  • CDR0000577866

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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