CA 125 Levels in Treating Patients With Relapsed Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Who Are Receiving Tamoxifen

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Estrogen may cause the growth of ovarian cancer cells. Hormone therapy using tamoxifen may fight ovarian cancer by blocking the use of estrogen by the tumor cells. Measuring CA 125 levels may help doctors predict a patient's response to tamoxifen and help plan the best treatment. PURPOSE: This phase II trial is studying CA 125 levels in treating patients with relapsed advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who are receiving tamoxifen.

Detailed Description
-----------------
OBJECTIVES: Determine the percentage of patients with relapsed advanced ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma who have a log linear rise in CA 125 levels. Determine whether the log linear part of the curve is consistent enough to allow comparison of the slope before and after introduction of a new therapy. Compare the serial doubling time before and after commencing tamoxifen citrate treatment. Determine the number of patients required to detect a significant difference in CA 125 doubling time before and after starting tamoxifen citrate treatment. OUTLINE: Patients undergo blood collection once a month to measure CA 125 levels. Once the CA 125 level goes above the upper limit of normal (ULN) or has started to rise from its nadir level (if not previously normal), CA 125 levels are measured every 2 weeks. When CA 125 levels reach 4 times the ULN or 4 times the nadir level (if not previously normal), patients begin oral tamoxifen citrate once daily for 3-6 months in the absence of disease progression or unacceptable toxicity. CA 125 levels will continue to be measured every 2 weeks during treatment. PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Official Title
-----------------
Use of Changes in CA 125 Doubling Time to Detect Activity of Cytostatic Agents in Women Relapsing With Ovarian Carcinoma. Study 1-Tamoxifen

Conditions
-----------------
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
-----------------
* Drug: tamoxifen citrate
* Other: diagnostic laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed advanced ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma Completed therapy for first relapse Had an elevated CA 125 level before starting relapse therapy with ≥ 50% fall by completion of that therapy or response according to RECIST criteria No significant cancer-related symptoms requiring urgent treatment PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy > 3 months Hemoglobin > 10 g/dL WBC > 2,500/mm^3 Platelet count > 100,000/mm^3 Creatinine < 2 times upper limit of normal (ULN) AST/ALT < 2 times ULN Bilirubin < 1.5 times ULN No evidence of significant clinical disorder or laboratory finding that would preclude study participation No psychiatric disorder that would preclude informed consent Not pregnant or nursing PRIOR CONCURRENT THERAPY: No other concurrent hormonal therapy, except hormone-replacement therapy Other concurrent medications allowed provided dose is stable
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tamoxifen citrate|nan|
|Other: diagnostic laboratory biomarker analysis|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who have a log linear rise in CA 125 levels |  |  | 
| Comparison of the slope before and after introduction of a new therapy in terms of consistency of the log linear part of the curve |  |  | 
| Comparison of the serial doubling time before and after commencing tamoxifen |  |  | 
| Number of patients required to detect a significant difference in CA 125 doubling time before and after starting tamoxifen |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, recurrent fallopian tube cancer, stage IIIA fallopian tube cancer, stage IIIB fallopian tube cancer, stage IIIC fallopian tube cancer, stage IV fallopian tube cancer, recurrent primary peritoneal cavity cancer, stage IIIA primary peritoneal cavity cancer, stage IIIB primary peritoneal cavity cancer, stage IIIC primary peritoneal cavity cancer, stage IV primary peritoneal cavity cancer