Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)

Nonresectable Adrenocortical Carcinoma Clinical Trial

Official title:

A Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215202
• Other study ID #: D0327
• Status: Completed
• Phase: Phase 2
• Start date: August 2004
• Est. completion date: January 2007

Study information

• Verified date: May 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

Adrenocortical carcinoma is a rare cancer with an incidence of 1.5 to 2 per million people in the United States. Surgery is the only potentially curative option. Current systemic therapy, either Mitotane or chemotherapy, typically gives response rates of 20% or less. This study is designed to see if the newer targeted therapy, Iressa, may be of benefit for patients with this fatal disease.

Patients with nonresectable adrenocortical cancer who have progressed on at least one other form of systemic therapy (Mitotane or chemotherapy) will be given Iressa 250 mg by mouth daily until disease progression. This is a standard two-stage Phase II clinical trial. Eighteen patients with measurable disease will be enrolled in the first stage. If there is at least one responder, then an additional nine patients with measurable disease will be enrolled for a total of 27 patients with measurable disease. Up to six patients without measurable disease may be enrolled at any point in this study. Iressa will be provided free for all study participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adrenocortical Carcinoma
• Carcinoma
• Nonresectable Adrenocortical Carcinoma

Intervention

Drug:
• Iressa (ZD1839)

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	The University of Texas M.D. Anderson Cancer Center	Houston	Texas
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Kentuckiana Cancer Institute PLLC	Louisville	Kentucky

Sponsors (5)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	AstraZeneca, Dana-Farber Cancer Institute, Kentuckiana Cancer Institute, M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to measure the objective response rate by RECIST (radiographic) criteria of nonresectable adrenocortical cancer to ZD1839
Secondary	Duration of response
Secondary	Adverse event profile
Secondary	Duration of survival
Secondary	Time to progression