Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00025220
Other study ID # NCI-2012-02415
Secondary ID NCI-2012-02415CD
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2001
Est. completion date July 2008

Study information

Verified date July 2019
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent cancer of the uterus. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 2008
Est. primary completion date April 2003
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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)

Study Design


Intervention

Drug:
Thalidomide
Given PO
Other:
Laboratory Biomarker Analysis
Correlative studies

Locations

Country Name City State
United States Gynecologic Oncology Group Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
National Cancer Institute (NCI) Gynecologic Oncology Group

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival 6 months
Primary Frequency and severity of adverse effects as assessed by CTC Up to 7 years
Secondary Duration of progression-free survival Up to 7 years
Secondary Duration of overall survival Up to 7 years
Secondary Frequency of clinical response (partial and complete response) Up to 7 years
See also
  Status Clinical Trial Phase
Completed NCT01168232 - Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer Phase 2
Completed NCT00025506 - Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus Phase 2
Completed NCT01220609 - Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy Phase 2
Terminated NCT01012297 - Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma Phase 3
Completed NCT01548482 - Trebananib And Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery Phase 1
Completed NCT00114218 - Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer Phase 2
Completed NCT01154452 - Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma Phase 1/Phase 2
Completed NCT01098630 - Patient, Physician, and Nurse Factors Associated With Entry Onto Clinical Trials and Finishing Treatment in Patients With Primary or Recurrent Uterine, Endometrial, or Cervical Cancer
Completed NCT01247571 - Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer Phase 2
Completed NCT00031629 - Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus Phase 2
Completed NCT01637961 - Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Phase 2