Clinical trial · Interventional
Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)
A Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)
NCT00215202CI-TRIAL-00032988completedPhase 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 use of Iressa will result in a greater than 20% response rate in patients with nonresectable adrenocortical cancer who have previously been treated with one other form of systemic therapy (either Mitotane or chemotherapy).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nonresectable Adrenocortical Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iressa (ZD1839) | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The primary objective of this study is to measure the objective response rate by RECIST (radiographic) criteria of nonresectable adrenocortical cancer to ZD1839
Secondary outcomes (4)
- measure
- Duration of response
- measure
- Adverse event profile
- measure
- Duration of survival
- measure
- Time to progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject must be able to provide informed consent * Subject must be 18 years of age or older * Subject must have histologically confirmed ACC by Department of Pathology at Dartmouth Hitchcock Medical Center * Subject must have inoperable disease * Subject must have received some form of systemic therapy prior to enrolling in the study Exclusion Criteria: * known severe hypersensitivity to Iressa * other co-existing malignancies diagnosed within the last five years except basal cell cancer or cervical cancer in situ * any unresolved CTC grade 2 toxicity from previous anticancer therapy (except alopecia) * absolute neutrophil count less than 1.5 x 1,000,000,000 per liter * platelets less than 20 x 1,000,000,000 per liter * severe uncontrolled systemic disease * pregnancy\\breastfeeding * women who are fertile and not willing to practice abstinence or contraception * use of phenytoin, carbamazepine, rifampicin, barbiturates, or St. John's Wort * treatment with a non-approved or investigational drug within 28 days before Day 1 of study treatment * prior use of ZD1839 (Iressa) or any other anti-EGFR therapies
References
Publications (0)
Data not yet available
No reference posted for this study.