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A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus


Phase 2
N/A
N/A
Not Enrolling
Female
Recurrent Uterine Sarcoma, Uterine Leiomyosarcoma

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Trial Information

A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus


PRIMARY OBJECTIVES:

I. Determine the antitumor cytostatic activity of thalidomide, as measured by the
probability of progression-free survival (PFS) for at least 6 months, in patients with
recurrent or persistent uterine leiomyosarcoma.

II. Determine the nature and degree of the toxicity of this drug in these patients.

III. Determine the partial and complete response rates in patients treated with this drug.

IV. Determine the duration of PFS and overall survival of patients treated with this drug.

V. Determine the effect of this drug on initial performance status in these patients.

VI. Determine the effects of this drug at 4 weeks on endogenous angiogenesis factors
(vascular endothelial growth factor and basic fibroblast growth factor) in plasma and urine
of these patients.

VII. Assess the association of endogenous angiogenesis factors with clinical outcome (PFS)
in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks in
the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.


Inclusion Criteria:



- Histologically confirmed primary uterine leiomyosarcoma (LMS) that is refractory to
curative therapy or established treatments

- Recurrent or persistent disease

- At least 1 unidimensionally measurable target lesion

- At least 20 mm by conventional techniques, including palpation, plain x-ray, CT
scan, or MRI OR at least 10 mm by spiral CT scan

- Tumors within a previously irradiated field are considered non-target lesions

- No smooth muscle tumor of uncertain malignant potential, including metastatic or
recurrent disease from such a tumor

- Must have received 1 prior initial chemotherapy regimen (including high-dose,
consolidation, or extended therapy after surgical or nonsurgical assessment) for
uterine LMS

- Ineligible for a higher priority Gynecological Oncology Group (GOG) protocol (if one
exists), including any active phase III protocol for the same patient population

- No documented brain metastases since diagnosis of cancer

- Patients with stable CNS deficits are allowed provided there are no brain
metastases, as confirmed by CT scan or MRI

- Performance status - GOG 0-2 if received 1 prior therapy regimen

- Performance status - GOG 0-1 if received 2 prior therapy regimens

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

- Creatinine no greater than 1.5 times ULN

- Creatinine clearance greater than 60 mL/min

- No documented seizure disorders since diagnosis of cancer

- Patients with a history of seizure disorders are allowed provided that the seizures
have been stable (i.e., no seizure within the past 12 months)while on an
appropriately monitored treatment regimen

- No active infection requiring antibiotics

- No greater than grade 1 sensory or motor neuropathy

- No other prior invasive malignancy within the past 5 years except nonmelanoma skin
cancer

- Not pregnant

- Negative pregnancy test

- Fertile patients must use at least 1 highly active method and 1 additional effective
method of contraception for at least 4 weeks before, during, and for at least 4 weeks
after study participation

- No prior thalidomide

- At least 3 weeks since prior immunologic agents for uterine LMS

- At least 3 weeks since other prior chemotherapy for uterine LMS and recovered

- No more than 1 prior cytotoxic chemotherapy regimen for recurrent or persistent
uterine LMS

- No prior non-cytotoxic chemotherapy for recurrent or persistent uterine LMS

- At least 1 week since prior hormonal therapy for uterine LMS

- Concurrent hormone replacement therapy allowed

- At least 3 weeks since prior radiotherapy for uterine LMS and recovered

- No prior radiotherapy to more than 25% of bone marrow

- Recovered from recent prior surgery

- No prior anticancer therapy that would preclude study therapy

- At least 3 weeks since other prior therapy for uterine LMS

- No concurrent bisphosphonates (e.g., zoledronate)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

D. Scott McMeekin

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02415

NCT ID:

NCT00025220

Start Date:

September 2001

Completion Date:

Related Keywords:

  • Recurrent Uterine Sarcoma
  • Uterine Leiomyosarcoma
  • Leiomyosarcoma
  • Uterine Neoplasms
  • Sarcoma

Name

Location

Gynecologic Oncology GroupPhiladelphia, Pennsylvania  19103