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

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ClinicalTrials.gov Identifier: NCT00215202
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 17, 2018
Sponsor:
Collaborators:
AstraZeneca
M.D. Anderson Cancer Center
Dana-Farber Cancer Institute
Kentuckiana Cancer Institute
Information provided by:
Dartmouth-Hitchcock Medical Center

September 15, 2005
September 22, 2005
May 17, 2018
August 2004
January 2007   (Final data collection date for primary 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
Same as current
Complete list of historical versions of study NCT00215202 on ClinicalTrials.gov Archive Site
  • Duration of response
  • Adverse event profile
  • Duration of survival
  • Time to progression
Same as current
Not Provided
Not Provided
 
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)
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).

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Nonresectable Adrenocortical Carcinoma
Drug: Iressa (ZD1839)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
33
January 2007
January 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00215202
D0327
Yes
Not Provided
Not Provided
Not Provided
Dartmouth-Hitchcock Medical Center
  • AstraZeneca
  • M.D. Anderson Cancer Center
  • Dana-Farber Cancer Institute
  • Kentuckiana Cancer Institute
Principal Investigator: Vivek Samnotra, MD Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP