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

NCT00215202 | Completed Phase 2 DMC

• 1 other identifier: D0327
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

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).

Conditions

Nonresectable Adrenocortical Carcinoma

Keywords

Adrenocortical Cancer; Iressa; Adrenal Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

• Duration of response

• Adverse event profile

• Duration of survival

• Time to progression

Interventions

Iressa (ZD1839) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• AstraZeneca: collaborator
• M.D. Anderson Cancer Center: collaborator
• Dana-Farber Cancer Institute: collaborator
• Kentuckiana Cancer Institute: collaborator

Study Sites (4)

Kentuckiana Cancer Institute PLLC

Louisville, Kentucky, 40202, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Vivek Samnotra, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2004
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

US (4)