Clinical trial · Interventional
Gefitinib in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
A Phase II Trial of ZD1839 (Iressa) (NSC# 715055) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
NCT00023699CI-TRIAL-00010964completedPhase 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)
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and may slow the growth of ovarian epithelial cancer or primary peritoneal cancer. PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
Conditions
Conditions (2)
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 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial or primary peritoneal carcinoma * Recurrent or persistent disease * Must have had prior therapy with no more than 1 platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or other organoplatinum compound) for primary disease * Platinum-resistant or refractory * Treatment-free interval of less than 6 months after therapy with platinum-containing regimen OR * Progression during platinum-containing regimen OR * Platinum sensitive defined as treatment-free interval without disease progression for more than 6 months but less than 12 months after therapy with platinum-containing regimen * At least 1 lesion measurable in at least 1 dimension * At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR * At least 10 mm by spiral CT scan * At least 1 target lesion outside a previously irradiated field * Disease must be accessible to core needle biopsy * Ineligible for higher priority GOG protocol PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * 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 Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No unstable cardiac disease * No myocardial infarction within the past 6 months * Coronary artery disease, congestive heart failure, and dysrhythmia allowed if on stable regimen for at least 3 months Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No sensory or motor neuropathy greater than grade 1 * No active corneal disease (e.g., keratoconjunctivitis) * No active infection requiring antibiotics * No evidence of bowel dysfunction that could be related to early bowel obstruction * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior immunological agents for the malignancy * No concurrent anti-cancer immunotherapy Chemotherapy: * See Disease Characteristics * No more than 1 additional prior cytotoxic chemotherapy regimen for recurrent or persistent disease * No prior noncytotoxic chemotherapy for recurrent or persistent disease * At least 3 weeks since prior chemotherapy for the malignancy and recovered * No concurrent anti-cancer chemotherapy Endocrine therapy: * At least 1 week since prior anticancer hormonal therapy * Concurrent hormone replacement therapy allowed * No concurrent anti-cancer hormonal therapy Radiotherapy: * See Disease Characteristics * At least 3 weeks since prior radiotherapy for the malignancy and recovered * No prior radiotherapy to more than 25% of marrow-bearing areas * No concurrent anti-cancer radiotherapy Surgery: * At least 4 weeks since prior surgery (except minor procedures under local anesthesia (e.g., central venous port placement)) and recovered Other: * At least 3 weeks since other prior therapy for the malignancy * No prior gefitinib * No other prior epidermal growth factor receptor inhibitors * No prior anticancer therapy that would preclude study therapy * No concurrent chlorpromazine * No other concurrent investigational agents * No other concurrent antineoplastic agents * No concurrent CYP3A4-inducing agents, including phenytoin, carbamazepine, barbiturates, nafcillin, rifampicin, or St. John's Wort
References
Publications (1)
- RESULTSchilder RJ, Sill MW, Chen X, Darcy KM, Decesare SL, Lewandowski G, Lee RB, Arciero CA, Wu H, Godwin AK. Phase II study of gefitinib in patients with relapsed or persistent ovarian or primary peritoneal carcinoma and evaluation of epidermal growth factor receptor mutations and immunohistochemical expression: a Gynecologic Oncology Group Study. Clin Cancer Res. 2005 Aug 1;11(15):5539-48. doi: 10.1158/1078-0432.CCR-05-0462. PMID 16061871