Clinical trial · Interventional
Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer
A Phase II Study of ZD1839 (Iressa) Plus Anastrozole (Arimidex) in Patients With Relapsed Ovarian Cancer
NCT00181688CI-TRIAL-00008601completedPhase 2ClinicalTrials.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)
The main purpose of this study is to determine the effects (good and bad) Iressa plus anastrozole has on patients with relapsed ovarian cancer.
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 |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Carcinoma | — | UNRESOLVED | — |
| Tubal Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arimidex (Anastrozole) | Drug | Anastrozole | ALIAS |
| Iressa (ZD1839) | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.
Secondary outcomes (2)
- measure
- To define the median time to progression of this patient population
- measure
- to assess the tumor response and safety of this treatment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic history diagnosis of primary ovarian, primary peritoneal or tubal carcinoma * Asymptomatic from ovarian cancer * Evidence of recurrent ovarian, peritoneal or tubal carcinoma * Tumor sample must be positive for ER and/or PR * 18 years of age or older * ECOG performance status of less than or equal to 1 * Must be able to tolerate oral intake Exclusion Criteria: * Known hypersensitivity to Iressa or any of the excipients of this product * Other coexisting malignancies or malignancies diagnosed within the last 5 years * Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital or St. John's wort * Treatment with a non-approved or investigational drug within 30 days * Any unresolved chronic toxicity greater than CTC grad 2 from previous anticancer therapy (except alopecia) * Incomplete healing from previous oncologic or other major surgery * Serum creatinine level greater than CTC grade 2 * Pregnant or breast feeding * Severe uncontrolled systemic disease * Significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate * Patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment * Patients previously treated with anastrozole or other aromatase inhibitor * Unable to tolerate oral medications * Clinical and/or radiographic evidence of current or impending bowel obstruction
References
Publications (0)
Data not yet available
No reference posted for this study.