Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00379145
First received: September 19, 2006
Last updated: August 14, 2012
Last verified: November 2008
  Purpose

RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well trabectedin works in treating patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus.


Condition Intervention Phase
Sarcoma
Drug: trabectedin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Trabectedin (Yondelis, R279741) in the Treatment of Advanced, Persistent, or Recurrent Uterine Leiomyosarcomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Frequency and duration of objective response as measured by RECIST criteria [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as measured by CTCAE v3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment: 43
Study Start Date: June 2007
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the antitumor activity of trabectedin, as measured by frequency and duration of objective response, in patients with advanced, persistent, or recurrent uterine leiomyosarcoma.
  • Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive trabectedin IV continuously over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve a confirmed complete response may receive at least 2 additional courses.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed uterine leiomyosarcoma

    • Histological confirmation of original primary tumor required
  • Advanced, persistent, or recurrent disease

    • Documented disease progression
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, and MRI OR ≥ 10 mm by spiral CT scan

    • At least 1 target lesion

      • Tumors within a previously irradiated field are considered nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiotherapy
  • Ineligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)

PATIENT CHARACTERISTICS:

  • GOG performance status 0-2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Platelet count ≥ 100,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Hemoglobin > 9.0 g/dL
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin normal
  • AST ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 1.5 times ULN
  • CPK ≤ ULN
  • No active infection requiring antibiotics (except for patients with uncomplicated UTI)
  • No neuropathy (sensory or motor) > grade 1
  • No other invasive malignancy within the past 5 years except for nonmelanoma skin cancer
  • No known active liver disease or hepatitis
  • Must be willing/able to have a central venous catheter

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior surgery, radiotherapy, or other therapy
  • No prior cancer treatment that would preclude study therapy
  • No prior cytotoxic chemotherapy or biologic therapy for uterine sarcoma
  • No prior chemotherapy for any abdominal or pelvic tumor within the past 5 years

    • Prior adjuvant chemotherapy for localized breast cancer is allowed provided it was completed more than 3 years ago and there is no evidence of recurrent or metastatic disease
  • No prior trabectedin
  • No prior radiotherapy within the past 5 years to any portion of the abdominal cavity or pelvis other than for treatment of uterine sarcoma

    • Prior radiotherapy for localized cancer of the breast, head and neck or skin is allowed, provided that it was completed more than 3 years ago and there is no evidence of recurrent or metastatic disease
  • At least 1 week since prior hormonal therapy for the malignancy (continuation of hormone replacement therapy is permitted)
  • No concurrent amifostine or other protective agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379145

  Hide Study Locations
Locations
United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Connecticut
Helen and Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States, 06050
United States, District of Columbia
Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Georgia
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912
Central Georgia Gynecologic Oncology
Macon, Georgia, United States, 31201
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
United States, Indiana
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Michigan
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
United States, Missouri
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Nevada
Women's Cancer Center - Lake Mead
Las Vegas, Nevada, United States, 89102
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Bradley J. Monk, MD Chao Family Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00379145     History of Changes
Other Study ID Numbers: CDR0000502192, GOG-0087M
Study First Received: September 19, 2006
Last Updated: August 14, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
uterine leiomyosarcoma
recurrent uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma

Additional relevant MeSH terms:
Leiomyosarcoma
Sarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Trabectedin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014