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

Gynecologic Oncology Group (GOG)

Status and phase

Completed

Phase 2

Conditions

Sarcoma

Treatments

Drug: trabectedin

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00379145

NCI-2009-00573 (Other Identifier)

GOG-0087M

CDR0000502192 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Female

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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