Clinical trial · Interventional
Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
A Randomized Study Of Tamoxifen Versus Thalidomide (NSC# 66847) In Patients With Biochemical-Recurrence-Only Epithelial Ovarian Cancer, Cancer Of The Fallopian Tube, And Primary Peritoneal Carcinoma After First Line Chemotherapy
- 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)
Randomized phase III trial to compare the effectiveness of tamoxifen with that of thalidomide in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Estrogen can stimulate the growth of some types of cancer cells. Hormone therapy using tamoxifen may fight cancer by blocking the uptake of estrogen. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known whether thalidomide is more effective than tamoxifen in treating ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Conditions
Conditions (5)
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 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
| Recurrent Ovarian Epithelial Cancer | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Ovarian Epithelial Cancer | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Ovarian Epithelial Cancer | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (thalidomide)
- description
- Patients receive oral thalidomide once daily on days 1-28.
- interventionNames
- Drug: thalidomide
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Arm II (tamoxifen)
- description
- Patients receive oral tamoxifen twice daily on days 1-28.
- interventionNames
- Drug: tamoxifen citrate
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Median Progression-free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed stage III or IV ovarian epithelial, fallopian tube, or primary peritoneal cancer that was treated with only 1 prior first-line chemotherapy regimen (platinum/taxane-based) * Clinically and radiologically without evidence of measurable and nonmeasurable disease * Symptomatic ascites and pleural effusions are considered nonmeasurable disease * Must have a biochemical recurrence * CA 125 must have been normal prior to or normalized during first-line therapy and then subsequently rose to exceed twice the upper limit of normal * Patients entering study with a CA 125 level less than 100 U/mL must be confirmed a second time within a period of not more than 4 weeks * Patients with a CA 125 level of at least 100 U/mL may be entered without confirmatory measurement * Ineligible for a higher priority Gynecologic Oncology Group protocol (if one exists) * No history of brain metastases * Performance status - GOG 0-1 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN * Creatinine no greater than 1.5 times ULN * Creatinine clearance at least 60 mL/min * No history of deep venous thrombosis * No prior cerebrovascular accident * No history of pulmonary embolism * No significant infection * No grade 2 or greater sensory or motor neuropathy * No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use at least 1 highly active method and at least 1 additional effective method of contraception for 4 weeks before, during, and for 4 weeks after study participation * No prior immunotherapy (e.g., interleukins) * No prior biological response modifiers (e.g., monoclonal antibodies) * No prior antiangiogenic agents (e.g., carbonic anhydrase inhibitors) * At least 3 weeks since prior anticancer chemotherapy and recovered * No prior or concurrent tamoxifen or other selective estrogen receptor modulators * At least 4 weeks since prior and no concurrent hormones (e.g., estrogen or progesterone) * At least 3 weeks since prior anticancer radiotherapy and recovered * At least 3 weeks since prior anticancer surgery and recovered * Prior second-look surgery without cytoreduction allowed * At least 3 weeks since other prior anticancer therapy and recovered * No prior interval cytoreduction * No concurrent full-dose therapeutic anticoagulation * No concurrent antiseizure medications for seizure disorder * No concurrent bisphosphonates (e.g., zoledronate)
References
Publications (0)
Data not yet available