Know Cancer

or
forgot password

Phase II Trial of Thalidomide in Patients With Ovarian Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

Phase II Trial of Thalidomide in Patients With Ovarian Cancer


OBJECTIVES:

- Determine the time to progression of disease in patients with platinum-refractory or
resistant ovarian epithelial carcinoma treated with thalidomide.

- Evaluate the quality of life of patients treated with this regimen.

OUTLINE: Patients receive oral thalidomide once daily. Treatment continues in the absence of
disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 4 weeks.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 9-15 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed ovarian epithelial carcinoma

- Platinum-refractory or resistant disease

- At least 1 prior non-platinum chemotherapy agent required

- Prior bilateral salpingo-oophorectomy and hysterectomy required

- Bidimensionally measurable disease OR CA-125 greater than 100 units/mm3

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- Karnofsky 70-100%

Life expectancy:

- More than 3 months

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin normal

- AST no greater than 2.5 times upper limit of normal (ULN)

Renal:

- Creatinine no greater than 1.5 times ULN OR

- Creatinine clearance at least 50 mL/min

Other:

- No other prior malignancy except non-melanoma skin cancer unless curatively treated
with no evidence of disease within the past 5 years and at low risk for recurrence

- No other clinical circumstances that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior biologic therapy and recovered

- No prior thalidomide

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks since prior cytotoxic therapy and recovered

Endocrine therapy:

- At least 4 weeks since prior hormonal therapy and recovered

Radiotherapy:

- At least 4 weeks since prior radiotherapy

Surgery:

- See Disease Characteristics

- At least 4 weeks since prior major surgery

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David R. Spriggs, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

01-006

NCT ID:

NCT00016224

Start Date:

January 2001

Completion Date:

March 2004

Related Keywords:

  • Ovarian Cancer
  • recurrent ovarian epithelial cancer
  • Ovarian Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021