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A Phase II Evaluation of Thalidomide (NSC #66847, IND 48832) in the Treatment of Recurrent of Persistent Endometrial Carcinoma


Phase 2
N/A
N/A
Not Enrolling
Female
Endometrial Adenoacanthoma, Endometrial Adenocarcinoma, Endometrial Adenosquamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Endometrial Papillary Serous Carcinoma, Recurrent Endometrial Carcinoma

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Trial Information

A Phase II Evaluation of Thalidomide (NSC #66847, IND 48832) in the Treatment of Recurrent of Persistent Endometrial Carcinoma


OBJECTIVES:

I. Determine the antitumor cytostatic activity of thalidomide, in terms of 6-month
progression-free survival, in patients with recurrent or persistent endometrial carcinoma.

II. Determine the nature and degree of 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 progression-free and overall survival in patients treated with
this drug.

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

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.


Inclusion Criteria:



- Histologically confirmed endometrial carcinoma

- Recurrent or persistent (refractory to curative therapy or established
treatment)

- No sarcomas

- At least 1 unidimensionally measurable 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

- At least 1 target lesion outside the area of prior radiotherapy

- Received 1 prior chemotherapy regimen for endometrial carcinoma

- Initial treatment may include high-dose therapy, consolidation, or extended
therapy

- No more than 1 additional cytotoxic regimen for recurrent or persistent disease

- No non-cytotoxic chemotherapy for recurrent or persistent disease

- Ineligible for higher priority GOG protocols (any active GOG phase III protocol for
the same patient population)

- No documented brain metastases since diagnosis of cancer

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

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

- Performance status - GOG 0-1 if patient received 2 prior 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 2 methods of effective contraception for 4 weeks before,
during, and for 4 weeks after study participation

- No active infection requiring antibiotics

- No sensory or motor neuropathy greater than grade 1

- No other invasive malignancy within the past 5 years except non-melanoma skin cancer

- No documented seizure disorders since diagnosis of cancer

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

- At least 3 weeks since prior biologic or immunologic agents directed at malignancy

- No prior thalidomide

- See Disease Characteristics

- At least 3 weeks since prior chemotherapy directed at malignancy and recovered

- At least 1 week since prior hormonal therapy directed at malignancy

- Concurrent hormone replacement therapy allowed

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy directed at malignancy and recovered

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

- Recovered from prior surgery

- At least 3 weeks since any other prior therapy directed at malignancy

- No prior cancer therapy that would preclude study participation

- 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:

Proportion of patients alive and progression-free

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-2012-02420

NCT ID:

NCT00025467

Start Date:

September 2001

Completion Date:

Related Keywords:

  • Endometrial Adenoacanthoma
  • Endometrial Adenocarcinoma
  • Endometrial Adenosquamous Cell Carcinoma
  • Endometrial Clear Cell Carcinoma
  • Endometrial Papillary Serous Carcinoma
  • Recurrent Endometrial Carcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Adenosquamous
  • Adenocarcinoma, Clear Cell
  • Adenomyoepithelioma
  • Cystadenocarcinoma, Serous
  • Adenoma
  • Endometrial Neoplasms

Name

Location

Gynecologic Oncology GroupPhiladelphia, Pennsylvania  19103