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


Phase 2
18 Years
N/A
Not Enrolling
Both
Nonresectable Adrenocortical Carcinoma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

The primary objective of this study is to measure the objective response rate by RECIST (radiographic) criteria of nonresectable adrenocortical cancer to ZD1839

Principal Investigator

Vivek Samnotra, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center

Authority:

United States: Institutional Review Board

Study ID:

D0327

NCT ID:

NCT00215202

Start Date:

August 2004

Completion Date:

January 2007

Related Keywords:

  • Nonresectable Adrenocortical Carcinoma
  • Adrenocortical Cancer
  • Iressa
  • Adrenal Cancer
  • Carcinoma
  • Adrenocortical Carcinoma

Name

Location

Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Dana Farber Cancer InstituteBoston, Massachusetts  02115
The University of Texas M.D. Anderson Cancer CenterHouston, Texas  
Kentuckiana Cancer Institute PLLCLouisville, Kentucky  40202