Know Cancer

forgot password

A Phase II Evaluation of Trabectedin (Yondelis, R279741) in the Treatment of Advanced, Persistent, or Recurrent Uterine Leiomyosarcomas

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

A Phase II Evaluation of Trabectedin (Yondelis, R279741) in the Treatment of Advanced, Persistent, or Recurrent Uterine Leiomyosarcomas


- Determine the antitumor activity of trabectedin, as measured by frequency and duration
of objective response, in patients with advanced, persistent, or recurrent uterine

- 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.

Inclusion Criteria


- 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/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


- No active infection requiring antibiotics (except for patients with uncomplicated

- No neuropathy (sensory or motor) > grade 1

- No other invasive malignancy within the past 5 years except for nonmelanoma skin

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and duration of objective response as measured by RECIST criteria

Safety Issue:


Principal Investigator

Bradley J. Monk, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Chao Family Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

June 2007

Completion Date:

Related Keywords:

  • Sarcoma
  • uterine leiomyosarcoma
  • recurrent uterine sarcoma
  • stage III uterine sarcoma
  • stage IV uterine sarcoma
  • Leiomyosarcoma
  • Sarcoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Duke Comprehensive Cancer Center Durham, North Carolina  27710
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain, Connecticut  06050
Hinsdale Hematology Oncology Associates Hinsdale, Illinois  60521
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44109
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Washington Cancer Institute at Washington Hospital Center Washington, District of Columbia  20010
St. John's Regional Health Center Springfield, Missouri  65804
SUNY Downstate Medical Center Brooklyn, New York  11203
Lake/University Ireland Cancer Center Mentor, Ohio  44060
St. Vincent Indianapolis Hospital Indianapolis, Indiana  46260
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
MBCCOP - Medical College of Georgia Cancer Center Augusta, Georgia  30912-3730
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Helen and Harry Gray Cancer Center at Hartford Hospital Hartford, Connecticut  06102-5037
Women's Cancer Center - Lake Mead Las Vegas, Nevada  89102
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
Rosenfeld Cancer Center at Abington Memorial Hospital Abington, Pennsylvania  19001
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Central Georgia Gynecologic Oncology Macon, Georgia  31201