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

NCT00379145 | Completed Phase 2 Results DMC

• 3 other identifiers: GOG-0087MCDR0000502192NCI-2009-00573
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 32

Brief 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.

Conditions

Sarcoma

Keywords

uterine leiomyosarcoma; recurrent uterine sarcoma; stage III uterine sarcoma; stage IV uterine sarcoma

Outcome Measures

Primary Outcomes (2)

• 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.

• 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

Study Arms (1)

Trabectedin

EXPERIMENTAL

Trabectedin IV over 24 hours every 3 weeks

Drug: trabectedin

Interventions

trabectedin DRUG

Trabectedin

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (32)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Helen and Harry Gray Cancer Center at Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

New Britain, Connecticut, 06050, United States

Location

Washington Cancer Institute at Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MBCCOP - Medical College of Georgia Cancer Center

Augusta, Georgia, 30912, United States

Location

Central Georgia Gynecologic Oncology

Macon, Georgia, 31201, United States

Location

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403-3089, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, 60521, United States

Location

St. Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Women's Cancer Center - Lake Mead

Las Vegas, Nevada, 89102, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131-5636, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MetroHealth Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210-1240, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Lake/University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Related Publications (2)

• 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. doi: 10.1016/j.ygyno.2006.04.025. Epub 2006 Jun 23.

  PMID: 16797679 BACKGROUND

• 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. doi: 10.1016/j.ygyno.2011.09.019. Epub 2011 Oct 13.

  PMID: 21996263 RESULT

MeSH Terms

Conditions

Sarcoma

Interventions

Trabectedin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Angela Kuras on behalf of James Kauderer
• Organization: NRG Oncology

kurasa@nrgoncology.org

716-845-5702

Study Officials

• Bradley J. Monk, MD

  Chao Family Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2006
• First Posted: September 21, 2006
• Study Start: June 1, 2007
• Primary Completion: January 1, 2012
• Last Updated: December 12, 2017
• Results First Posted: December 12, 2017

Record last verified: 2015-05

Locations

US (32)