Brief Title
CA 125 Levels in Treating Patients With Relapsed Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Who Are Receiving Tamoxifen
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Percentage of patients who have a log linear rise in CA 125 levels
Condition
Fallopian Tube Cancer
Intervention
tamoxifen citrate
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
200
Start Date
March 2004
Primary Completion Date
December 2008
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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Gordon J.S. Rustin, MD, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT00305838
Organization ID
CDR0000463518
Secondary IDs
CDR0000463518
Study Sponsor
Mount Vernon Cancer Centre at Mount Vernon Hospital
Study Sponsor
Gordon J.S. Rustin, MD, Study Chair, Mount Vernon Cancer Centre at Mount Vernon Hospital
Verification Date
June 2009