Clinical trial · Interventional
Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane
A Randomized Study of Chemotherapy Versus Hormonal Treatment in Patients With Ovarian Cancer Resistant or Refractory to Platinum and Taxane
NCT02728622CI-TRIAL-00021629completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
A randomized study of chemotherapy versus hormonal treatment in patients with ovarian cancer resistant or refractory to platinum and taxane.
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 |
|---|---|---|---|
| Cancer of the Fallopian Tube | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tamoxifen
- description
- Tamoxifen 40 mg is given orally once daily until progression
- interventionNames
- Drug: Tamoxifen
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- description
- Paclitaxel 80 mg/m2 is given as an 1 hour infusion every 7 days or Caelyx 40 mg/m2 is given iv, first dose over 2 hours, later doses are infused over 1 hour, administered every 4 weeks or up to a maximum dose of 550 mg/m2. Until progression
- interventionNames
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Quality-adjusted survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with invasive epithelial ovarian, fallopian tube or peritoneal cancer, being resistant to treatment with platinum and a taxane, either given in combination or sequentially. * Patients with clinical progression during or within 6 months after end of treatment for primary disease or relapse. * Patients with stable disease after 6 courses of chemotherapy for primary disease or relapse if further treatment is indicated. * Patients with doubling of s-CA 125 to at least 70 IU/Ml within 3 months after end of treatment for primary disease or relapse. * Age must be at least 18 years. * Performance status must be 0-2 (WHO/ECOG, appendix 1). * Informed consent given according to ICH/EU GCP guidelines and local or national laws Exclusion Criteria: * Patients with symptomatic brain metastasis * Bilirubin greater than 2 x UNL (upper normal limits), white blood cell count below 3.0 x 109/L, neutrophil count below 1.5 x 109/L, platelets count below 100 x 109/L. * Active infection or other serious underlying medical condition which might prevent the patient from receiving treatment or to be followed. * Pregnant, lactating, or child bearing potential patients without adequate contraception * Previous treatment with Tamoxifen.
References
Publications (0)
Data not yet available
No reference posted for this study.