Nonresectable Adrenocortical CarcinomaPhase 2NCT00215202
Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)
A Phase 2 study testing Iressa (ZD1839) in people with Nonresectable Adrenocortical Carcinoma, run by Dartmouth-Hitchcock Medical Center at 4 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonresectable Adrenocortical Carcinoma
- What is being tested?
- Iressa (ZD1839)
- How many people
- 16 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2004to Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Kentuckiana Cancer Institute PLLC
Louisville, Kentucky, 40202
About this study
Official title: 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).
Read the 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.
- Conditions
- Nonresectable Adrenocortical Carcinoma
- Being tested
- Iressa (ZD1839)
- Keywords
- Adrenocortical Cancer, Iressa, Adrenal Cancer
- Medical subject headings
- Adrenal Cortex Neoplasms, Adrenal Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iressa (ZD1839)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonresectable Adrenocortical CarcinomaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, M.D. Anderson Cancer Center, Dana-Farber Cancer Institute, Kentuckiana Cancer Institute
- Investigators
- Vivek Samnotra, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215202
- Sponsor's protocol ID
- D0327
- Status last verified
- May 2018
- First submitted
- 15 Sep 2005
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)
- ClinicalTrials.gov ID
- NCT00215202
- Acronym / sponsor ID
- D0327
- Conditions
- Nonresectable Adrenocortical Carcinoma
- Keywords
- Adrenocortical Cancer, Iressa, Adrenal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- AstraZeneca, M.D. Anderson Cancer Center, Dana-Farber Cancer Institute, Kentuckiana Cancer Institute
- Study start
- Aug 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iressa (ZD1839) | Drug | – |
Primary outcome
The primary objective of this study is to measure the objective response rate by RECIST (radiographic) criteria of nonresectable adrenocortical cancer to ZD1839
4 secondary outcomes
Duration of response
Adverse event profile
Duration of survival
Time to progression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Samnotra, MD principal investigator
Dartmouth-Hitchcock Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iressa (ZD1839) in people with Nonresectable Adrenocortical Carcinoma, run by Dartmouth-Hitchcock Medical Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018.