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

ClinicalTrials.gov ID

NCT00305838

Lead Sponsor

Mount Vernon Cancer Centre at Mount Vernon HospitalOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 2

Enrollment

200Estimated

Last Update Posted

Aug 12, 2013Estimated

Start Date

Mar 2004

Primary Completion Date

Dec 2008Estimated

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

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.

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cavity Cancer

• tamoxifen citrate
• diagnostic laboratory biomarker analysis

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

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

Primary Purpose

Diagnostic

Masking

None (Open Label)

Lead Sponsor

Mount Vernon Cancer Centre at Mount Vernon HospitalOTHER

44-1332-347-141

Jamie.Morgan@ipswichhospital.nhs.uk44-1473-704-910

44-1923-844-190

44-122-455-3659

44-1248-384-331

• Early Chemotherapy Based on CA 125 Level Alone Compared With Delayed Chemotherapy in Treating Patients With Recurrent Ovarian Epithelial , Fallopian Tube, or Primary Peritoneal Cancer

  NCT00002895

  CompletedInterventionalPhase 3Updated Dec 4, 2013
• A Multicenter Trial On The Utility and Impact Of Computed Tomography and Serum CA-125 In the Management of Newly Diagnosed Ovarian Cancer

  NCT00587093

  CompletedInterventionalNot ApplicableUpdated Feb 22, 2018
• A Phase II Study of ZD1839 and Tamoxifen in Patients With Epithelial Ovarian Carcinoma, Cancer of the Fallopian Tube or the Peritoneum Refractory to Platinum- and Taxane-based Therapy

  NCT00189358

  CompletedInterventionalPhase 2Updated Jul 20, 2010
• Predictors of Relapse of Ovarian, Peritoneal, and Fallopian Tube Cancers

  NCT00086567

  CompletedObservationalUpdated Sep 1, 2026
• CA125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women

  NCT00058032

  CompletedInterventionalNot ApplicableUpdated Nov 19, 2020
• A Trial of Tamoxifen and Letrozole in Recurrent and Persistent Squamous Cell Carcinoma of the Cervix

  NCT02482740

  Unknown statusInterventionalPhase 2Updated Jun 26, 2015