Kidney CancerPhase 2NCT00014183
ZD 1839 in Treating Patients With Stage IV or Recurrent Kidney Cancer
A Phase 2 study testing gefitinib in people with Kidney Cancer, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of kidney cancer. PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have recurrent or stage IV kidney cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- gefitinib
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Jan 2001to Aug 2005
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed stage IV or recurrent renal cell carcinoma not amenable to potentially curative surgery
- Evidence of disease progression
- Measurable disease
- At least 20 mm with conventional techniques OR
- At least 10 mm with spiral CT scan
- No brain metastases
- Malignant tissue available
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy:
- More than 2 months
Hematopoietic:
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin normal
- AST/ALT no greater than 2.5 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other:
- No prior allergy to compounds of similar chemical or biologic composition to ZD 1839
- No ongoing or active infection
- No other uncontrolled illness or psychiatric condition that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No more than 2 prior immunotherapy (interferon alfa or interleukin-2) regimens
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunotherapy
Chemotherapy:
- No more than 1 prior chemotherapy regimen
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- No prior therapy for metastatic disease
- No other concurrent investigational agents
- No concurrent oral retinoids
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
About this study
Official title: A Phase II Study Of ZD1839 (NSC #715055) In Renal Cell Carcinoma Stage IV And Renal Cell Carcinoma Recurrent
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of kidney cancer.
PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have recurrent or stage IV kidney cancer.
Read the detailed description
OBJECTIVES:
- Determine the response rate in patients with progressive stage IV or recurrent renal cell cancer treated with ZD 1839.
- Determine the median time to objective progression in these patients receiving this drug.
- Determine the toxic effects of this drug in this patient population.
- Determine if epidermal growth factor receptor expression in tumor tissue correlates with response and survival of these patients.
OUTLINE: This is a multicenter study.
Patients receive oral ZD 1839 daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 11-23 months.
- Conditions
- Kidney Cancer
- Being tested
- gefitinib
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gefitinibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2004 (estimated)
- Study startJan 2001
- Primary completionMay 2002
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Maryland Greenebaum Cancer Center
- Responsible party
- Sponsor
- Investigators
- Nancy A. Dawson, MD, Study chair, University of Maryland Greenebaum Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014183
- Sponsor's protocol ID
- CDR0000068512
- Other IDs
- MSGCC-0044, NCI-1639
- Status last verified
- Nov 2019
- First submitted
- 10 Apr 2001
- Last updated
- 7 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of ZD1839 (NSC #715055) In Renal Cell Carcinoma Stage IV And Renal Cell Carcinoma Recurrent
- ClinicalTrials.gov ID
- NCT00014183
- Acronym / sponsor ID
- CDR0000068512
- Conditions
- Kidney Cancer
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Maryland Greenebaum Cancer Center
- Study start
- Jan 2001
- Primary completion
- May 2002 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 1 Jan 2004 (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.
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of kidney cancer.
PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have recurrent or stage IV kidney cancer.
Detailed description
OBJECTIVES:
- Determine the response rate in patients with progressive stage IV or recurrent renal cell cancer treated with ZD 1839.
- Determine the median time to objective progression in these patients receiving this drug.
- Determine the toxic effects of this drug in this patient population.
- Determine if epidermal growth factor receptor expression in tumor tissue correlates with response and survival of these patients.
OUTLINE: This is a multicenter study.
Patients receive oral ZD 1839 daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 11-23 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| gefitinib | Drug | – |
Primary outcome
Not reported in the source record.
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 7 Nov 2019.
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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.
Nancy A. Dawson, MD study chair
University of Maryland Greenebaum Cancer Center
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 gefitinib in people with Kidney Cancer, run by University of Maryland, Baltimore 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?
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 7 Nov 2019. 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.
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 7 Nov 2019.