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

This study has been suspended.
Verified By National Cancer Institute (NCI), November 2008
Sponsors:Gynecologic Oncology Group
Collaborator:National Cancer Institute (NCI)
Information Provided by:National Cancer Institute (NCI) Identifier:NCT00379145


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.

SarcomaDrug: trabectedinPhase2
U.S. FDA Resources
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
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
Estimated Completion Date:March 2009
Intervention Details:Drug: trabectedin
Detail Description:
  • 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.


Ages Eligible for Study:18 Years And Older
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No
  • 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)
  • GOG performance status 0-2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Platelet count ??? 100,000/mm
  • Absolute neutrophil count ??? 1,500/mm
  • 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
  • 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

Please refer to this study by its identifier: NCT00379145
Sponsors And Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Bradley J. Monk, MDChao Family Comprehensive Cancer Center

More Information

Additional Information:
Study ID Numbers:CDR0000502192 ,  GOG-0087M
Study First Received:2006-09-19
Last Updated:2009-04-14 Identifier:NCT00379145
Health Authority:United States: Federal Government

In some instances, trial status may not reflect current status at Wake Forest Baptist Medical Center.

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