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Phase II Study of Two Dose Levels of Toremifene in the Treatment of Chemotherapy-Resistant Papillary Carcinoma of the Ovary


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

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Trial Information

Phase II Study of Two Dose Levels of Toremifene in the Treatment of Chemotherapy-Resistant Papillary Carcinoma of the Ovary


OBJECTIVES:

- Determine the effects of toremifene in terms of response rate, duration of response,
duration of survival, and toxicity in patients with chemotherapy resistant papillary
carcinoma of the ovary.

- Assess whether a dose response effect is likely for this regimen in these patients.

- Assess quality of life of these patients.

OUTLINE: This is a randomized study.

Patients receive one of two doses of oral toremifene daily for 4 weeks. Treatment continues
in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before therapy and then every 4 weeks during therapy.

Patients are followed every 12 weeks until death.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed serous papillary carcinoma of the ovary

- Recurrent or refractory disease following at least one regimen including
paclitaxel, cisplatin, or carboplatin

- Measurable disease outside of irradiated field

- No CNS metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Zubrod 0-2

Life expectancy:

- At least 16 weeks

Hematopoietic:

- Absolute neutrophil count at least 1,800/mm^3

- Platelet count at least 125,000/mm^3

- No history of thrombosis or thromboembolic events

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

Renal:

- Creatinine no greater than 2.0 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after study

- No other concurrent second malignancy or prior malignancy within past 5 years, except
basal or squamous cell skin cancer or curatively treated stage I carcinoma of the
cervix

- No concurrent infection

- At least 3 days since prior fever (unless due to tumor)

- No other concurrent severe medical illness

- No HIV positivity

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- No concurrent chemotherapy

Endocrine therapy:

- No prior tamoxifen or antiestrogen therapy

Radiotherapy:

- See Disease Characteristics

- At least 6 months since prior radiotherapy

- No concurrent radiotherapy except to symptomatic or potentially disabling bone lesion
accompanied by other measurable disease

Surgery:

- Not specified

Other:

- No concurrent anticoagulants

- No other concurrent therapeutic trials

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

James D. Ahlgren, MD

Investigator Role:

Study Chair

Investigator Affiliation:

George Washington University

Authority:

United States: Federal Government

Study ID:

CDR0000067029

NCT ID:

NCT00003865

Start Date:

July 1999

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • recurrent ovarian epithelial cancer
  • ovarian serous cystadenocarcinoma
  • Carcinoma, Papillary
  • Ovarian Neoplasms

Name

Location

George Washington University Cancer CenterWashington, District of Columbia  20037