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A Phase II Evaluation of Thalidomide (NSC #66847, IND 48832) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus


Phase 2
N/A
N/A
Open (Enrolling)
Female
Recurrent Uterine Sarcoma, Uterine Carcinosarcoma

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Trial Information

A Phase II Evaluation of Thalidomide (NSC #66847, IND 48832) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus


OBJECTIVES: Primary 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 carcinosarcoma.

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

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

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

III. Determine the effect of this drug on initial performance status and histological grade
in these patients.

IV. Correlate serum and plasma biomarkers, including vascular endothelial growth factor and
basic fibroblast growth factor, with clinical outcome (i.e., 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 28 days 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.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 3 years.


Inclusion Criteria:



- Histologically confirmed uterine sarcoma

- Carcinosarcoma (malignant mixed müllerian tumor)

- Homologous or heterologous type

- Recurrent or persistent with documented disease progression after prior local therapy

- At least 1 unidimensionally measurable target lesion

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

- At least 10 mm by spiral CT scan

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

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

- No documented brain metastases since diagnosis of cancer

- Patients with stable CNS deficits are allowed provided that there is no evidence
of brain metastases on CT scan or MRI

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

- 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

- Not pregnant

- Negative pregnancy test

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

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

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

- No prior thalidomide

- See Disease Characteristics

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

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

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

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

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

- Concurrent hormone replacement therapy allowed

- See Disease Characteristics

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

- No prior radiotherapy to more than 25% of marrow-bearing areas

- See Disease Characteristics

- Recovered from prior surgery

- At least 3 weeks since any other prior therapy for uterine sarcoma

- No prior anticancer therapy that would preclude study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Proportion of patients alive

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-2012-02421

NCT ID:

NCT00025506

Start Date:

September 2001

Completion Date:

Related Keywords:

  • Recurrent Uterine Sarcoma
  • Uterine Carcinosarcoma
  • Carcinosarcoma
  • Mixed Tumor, Mullerian
  • Uterine Neoplasms
  • Sarcoma

Name

Location

Gynecologic Oncology GroupPhiladelphia, Pennsylvania  19103