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

Primary Purpose

Nonresectable Adrenocortical Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Iressa (ZD1839)
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nonresectable Adrenocortical Carcinoma focused on measuring Adrenocortical Cancer, Iressa, Adrenal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kentuckiana Cancer Institute PLLC
  • Dana Farber Cancer Institute
  • Dartmouth-Hitchcock Medical Center
  • The University of Texas M.D. Anderson Cancer Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of response
Adverse event profile
Duration of survival
Time to progression

Full Information

First Posted
September 15, 2005
Last Updated
May 16, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
AstraZeneca, M.D. Anderson Cancer Center, Dana-Farber Cancer Institute, Kentuckiana Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00215202
Brief Title
Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)
Official Title
A Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
AstraZeneca, M.D. Anderson Cancer Center, Dana-Farber Cancer Institute, Kentuckiana Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonresectable Adrenocortical Carcinoma
Keywords
Adrenocortical Cancer, Iressa, Adrenal Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Iressa (ZD1839)
Primary Outcome Measure Information:
Title
The primary objective of this study is to measure the objective response rate by RECIST (radiographic) criteria of nonresectable adrenocortical cancer to ZD1839
Secondary Outcome Measure Information:
Title
Duration of response
Title
Adverse event profile
Title
Duration of survival
Title
Time to progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek Samnotra, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kentuckiana Cancer Institute PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
The University of Texas M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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