Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

Bradley J. Monk

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00379145
Information obtained from ClinicalTrials.gov on November 20, 2012