Ovarian CancerPhase 2NCT00181688
Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer
A Phase 2 study testing Iressa (ZD1839) and Arimidex (Anastrozole) in people with Ovarian Cancer and Peritoneal Carcinoma, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The main purpose of this study is to determine the effects (good and bad) Iressa plus anastrozole has on patients with relapsed ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Peritoneal Carcinoma, Tubal Carcinoma
- What is being tested?
- Iressa (ZD1839) and Arimidex (Anastrozole)
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2003to Mar 2006
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or cytologic history diagnosis of primary ovarian, primary peritoneal or tubal carcinoma
- Asymptomatic from ovarian cancer
- Evidence of recurrent ovarian, peritoneal or tubal carcinoma
- Tumor sample must be positive for ER and/or PR
- 18 years of age or older
- ECOG performance status of less than or equal to 1
- Must be able to tolerate oral intake
Who cannot join
- Known hypersensitivity to Iressa or any of the excipients of this product
- Other coexisting malignancies or malignancies diagnosed within the last 5 years
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital or St. John's wort
- Treatment with a non-approved or investigational drug within 30 days
- Any unresolved chronic toxicity greater than CTC grad 2 from previous anticancer therapy (except alopecia)
- Incomplete healing from previous oncologic or other major surgery
Show all 14Show fewer
- Serum creatinine level greater than CTC grade 2
- Pregnant or breast feeding
- Severe uncontrolled systemic disease
- Significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate
- Patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment
- Patients previously treated with anastrozole or other aromatase inhibitor
- Unable to tolerate oral medications
- Clinical and/or radiographic evidence of current or impending bowel obstruction
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Study of ZD1839 (Iressa) Plus Anastrozole (Arimidex) in Patients With Relapsed Ovarian Cancer
The main purpose of this study is to determine the effects (good and bad) Iressa plus anastrozole has on patients with relapsed ovarian cancer.
Read the detailed description
- Patients will receive Iressa and anastrozole orally once daily until treatment is ended. Treatment will end if any of the following occur: Unacceptable adverse effects; bowel obstruction; initiation of systemic chemotherapy; development of new ascites or pleural effusions, development of co-morbid disease or disease progression.
- Patients will be given a drug log in which to record the date and time they take their pills, as well as any symptoms and concomitant medications.
- Patients will be seen monthly for the following tests and procedures; a physical examination and repeat blood work. Patients who remain free of clinical symptoms should have repeat abdominal/pelvic CT scans and chest x-rays on an every 3 month basis.
- Conditions
- Ovarian Cancer, Peritoneal Carcinoma, Tubal Carcinoma
- Being tested
- Iressa (ZD1839), Arimidex (Anastrozole)
- Keywords
- Iressa, ZD1839, Anastrozole, Arimidex
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iressa (ZD1839)Drug
Arimidex (Anastrozole)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.
Secondary outcomes (2)
To define the median time to progression of this patient population
to assess the tumor response and safety of this treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital
- Responsible party
- Principal investigator, Carolyn N. Krasner, MD, Massachusetts General Hospital
- Investigators
- Carolyn Krasner, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181688
- Sponsor's protocol ID
- 03-250
- Status last verified
- Dec 2012
- First submitted
- 12 Sep 2005
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of ZD1839 (Iressa) Plus Anastrozole (Arimidex) in Patients With Relapsed Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00181688
- Acronym / sponsor ID
- 03-250
- Conditions
- Ovarian Cancer, Peritoneal Carcinoma, Tubal Carcinoma
- Keywords
- Iressa, ZD1839, Anastrozole, Arimidex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital
- Study start
- Oct 2003
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 16 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 main purpose of this study is to determine the effects (good and bad) Iressa plus anastrozole has on patients with relapsed ovarian cancer.
Detailed description
- Patients will receive Iressa and anastrozole orally once daily until treatment is ended. Treatment will end if any of the following occur: Unacceptable adverse effects; bowel obstruction; initiation of systemic chemotherapy; development of new ascites or pleural effusions, development of co-morbid disease or disease progression.
- Patients will be given a drug log in which to record the date and time they take their pills, as well as any symptoms and concomitant medications.
- Patients will be seen monthly for the following tests and procedures; a physical examination and repeat blood work. Patients who remain free of clinical symptoms should have repeat abdominal/pelvic CT scans and chest x-rays on an every 3 month basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologic or cytologic history diagnosis of primary ovarian, primary peritoneal or tubal carcinoma
- Asymptomatic from ovarian cancer
- Evidence of recurrent ovarian, peritoneal or tubal carcinoma
- Tumor sample must be positive for ER and/or PR
- 18 years of age or older
Key exclusion criteria (14 listed)
- Known hypersensitivity to Iressa or any of the excipients of this product
- Other coexisting malignancies or malignancies diagnosed within the last 5 years
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital or St. John's wort
- Treatment with a non-approved or investigational drug within 30 days
- Any unresolved chronic toxicity greater than CTC grad 2 from previous anticancer therapy (except alopecia)
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 | – |
| Arimidex (Anastrozole) | Drug | – |
Primary outcome
To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.
2 secondary outcomes
To define the median time to progression of this patient population
to assess the tumor response and safety of this treatment.
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 5 Dec 2012.
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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.
Carolyn Krasner, MD principal investigator
Massachusetts General Hospital
2 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) and Arimidex (Anastrozole) in people with Ovarian Cancer and Peritoneal Carcinoma, run by Massachusetts General Hospital at 2 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 7 inclusion and 14 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 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.. 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 5 Dec 2012.