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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379145
• Other study ID #: GOG-0087M
• Secondary ID: CDR0000502192NCI
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2006
• Last updated: November 10, 2017
• Start date: June 2007

Study information

• Verified date: May 2015
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyosarcoma
• Sarcoma

Intervention

Drug:
• trabectedin

Locations

Country	Name	City	State
United States	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	MBCCOP - Medical College of Georgia Cancer Center	Augusta	Georgia
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	MetroHealth Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	USC/Norris Comprehensive Cancer Center and Hospital	El Pueblo De Nuestra Señora De Los Ángeles De Porciúncula	California
United States	Helen and Harry Gray Cancer Center at Hartford Hospital	Hartford	Connecticut
United States	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois
United States	St. Vincent Indianapolis Hospital	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Women's Cancer Center - Lake Mead	Las Vegas	Nevada
United States	Central Georgia Gynecologic Oncology	Macon	Georgia
United States	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin
United States	Lake/University Ireland Cancer Center	Mentor	Ohio
United States	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus	New Britain	Connecticut
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Washington Cancer Institute at Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Monk BJ, Blessing JA, Street DG, Muller CY, Burke JJ, Hensley ML. A phase II evaluation of trabectedin in the treatment of advanced, persistent, or recurrent uterine leiomyosarcoma: a gynecologic oncology group study. Gynecol Oncol. 2012 Jan;124(1):48-52. — View Citation

Tewari D, Saffari B, Cowan C, Wallick AC, Koontz MZ, Monk BJ. Activity of trabectedin (ET-743, Yondelis) in metastatic uterine leiomyosarcoma. Gynecol Oncol. 2006 Sep;102(3):421-4. Epub 2006 Jun 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0	RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as 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. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.	CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.
Primary	Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0		Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up