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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00569673
Recruitment Status : Completed
First Posted : December 7, 2007
Results First Posted : June 26, 2014
Last Update Posted : July 18, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Tracking Information
First Submitted Date  ICMJE December 6, 2007
First Posted Date  ICMJE December 7, 2007
Results First Submitted Date  ICMJE May 27, 2014
Results First Posted Date  ICMJE June 26, 2014
Last Update Posted Date July 18, 2018
Study Start Date  ICMJE March 2008
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
  • 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
  • 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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2007)
  • Frequency and duration of objective tumor response
  • Frequency and Severity of Adverse Events as Assessed by CTCAE v3.0
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2014)
Duration of Progression-free Survival and Overall Survival [ Time Frame: up to 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2007)
Duration of Progression-free Survival and Overall Survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
Intervention  ICMJE
  • Biological: filgrastim
  • Biological: pegfilgrastim
  • Drug: docetaxel
  • Drug: trabectedin
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2014)
71
Original Enrollment  ICMJE
 (submitted: December 6, 2007)
70
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00569673
Other Study ID Numbers  ICMJE GOG-0186F
GOG-0186F
CDR0000577866
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gynecologic Oncology Group
Study Sponsor  ICMJE Gynecologic Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Bradley J. Monk, MD Chao Family Comprehensive Cancer Center
Investigator: Kristine M. Zanotti, MD MacDonald Physicians, Incorporated at University MacDonald Womens Hospital
PRS Account Gynecologic Oncology Group
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP