Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
This study has been suspended.
Verified By National Cancer Institute (NCI), November 2008
| Sponsors: | Gynecologic Oncology Group |
| Collaborator: | National Cancer Institute (NCI) |
| Information Provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00379145 |
Purpose
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.
U.S. FDA Resources| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment |
| Official Title: | A Phase II Evaluation of Trabectedin (Yondelis, R279741) in the Treatment of Advanced, Persistent, or Recurrent Uterine Leiomyosarcomas |
Further study details as provided by National Cancer Institute (NCI)
Primary Outcome Measures:- Frequency and duration of objective response as measured by RECIST criteria
[ Designated as safety issue: No ]
- Frequency and severity of adverse effects as measured by CTCAE v3.0
[ Designated as safety issue: Yes ]
| Estimated Enrollment: | 43 |
| Study Start Date: | June 2007 |
| Estimated Completion Date: | March 2009 |
| Intervention Details: | Drug:
| trabectedin | |
Detail 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.
Eligibility
| Ages Eligible for Study: | 18 Years
And Older
|
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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/mm
- Absolute neutrophil count ??? 1,500/mm
- 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
Contacts And Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379145
Locations
Sponsors And Collaborators
Gynecologic Oncology Group |
| National Cancer Institute (NCI) |
Investigators
| Study Chair:
| Bradley J. Monk, MD | Chao Family Comprehensive Cancer Center |
More Information
Additional Information:
| Study ID Numbers: | CDR0000502192
,
GOG-0087M |
| Study First Received: | 2006-09-19 |
| Last Updated: | 2009-04-14 |
| ClinicalTrials.gov Identifier: | NCT00379145 |
| Health Authority: | United States: Federal Government |