Clinical trial · Interventional
CA 125 Levels in Treating Patients With Relapsed Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Who Are Receiving Tamoxifen
Use of Changes in CA 125 Doubling Time to Detect Activity of Cytostatic Agents in Women Relapsing With Ovarian Carcinoma. Study 1-Tamoxifen
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diagnostic laboratory biomarker analysis | Other | — | UNRESOLVED |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Percentage of patients who have a log linear rise in CA 125 levels
- measure
- Comparison of the slope before and after introduction of a new therapy in terms of consistency of the log linear part of the curve
- measure
- Comparison of the serial doubling time before and after commencing tamoxifen
- measure
- Number of patients required to detect a significant difference in CA 125 doubling time before and after starting tamoxifen
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available