Clinical trial NCT00003865: Toremifene in Treating Patients With Ovarian Cancer
Official title: Phase II Study of Two Dose Levels of Toremifene in the Treatment of Chemotherapy-Resistant Papillary Carcinoma of the Ovary
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: recurrent ovarian epithelial cancer
ovarian serous cystadenocarcinoma
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2003-01-27
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Estrogen can stimulate the growth of ovarian cancer cells. Hormone therapy using toremifene may fight ovarian cancer by reducing the production of estrogen.

PURPOSE: Randomized phase II trial to study the effectiveness of toremifene in treating patients who have recurrent or refractory ovarian cancer.

Detailed description: 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: The study was closed before any patient accrual.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: George Washington University Cancer Center
state: District of Columbia
Study officials:
affiliation: George Washington University
name: James D. Ahlgren, MD
role: STUDY_CHAIR
References: