Recurrent Renal Cell CancerPhase 2NCT00009919
SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment
A Phase 2 study testing semaxanib in people with Recurrent Renal Cell Cancer and Stage IV Renal Cell Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic kidney cancer that has not responded to previous therapy with interleukin-2. SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer
- What is being tested?
- semaxanib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2000to Jun 2003
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed metastatic renal cell carcinoma
- Prior removal of primary tumors
- Bidimensionally measurable disease
- Bone-only disease is not considered measurable
- Progressive disease following no more than 2 prior biologic therapy (e.g.,interleukin-2, interferon alfa, vaccine, or dendritic cell therapy) orfluorouracil-containing (single-agent or in combination therapy) regimens
- No known history of CNS metastasis unless all of the following are true:
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- Previously treated
- Neurologically stable
- No requirement for IV steroids or anticonvulsants
- No requirement for oral steroids and no evidence of active or residual CNS disease on CT scan or MRI
- Negative brain scan (CT scan or MRI) required if neurologic signs or symptoms suggestive of CNS metastasis present
- Performance status - Zubrod 0-2
- At least 12 weeks
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count greater than 100,000/mm^3
- Bilirubin no greater than 1.5 mg/dL
- SGPT no greater than 2.5 times upper limit of normal
- PT and PTT normal
- Fibrinogen normal
- D-Dimer assay normal
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- See Surgery
- No active congestive heart failure
- No uncontrolled angina
- No myocardial infarction or severe/unstable angina within the past 6 months
- No uncontrolled hypertension
- No uncompensated coronary artery disease on electrocardiogram or physical examination
- No severe peripheral vascular disease
- No deep vein or arterial thrombosis within the past 3 months
- No pulmonary embolism within the past 3 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent serious infection
- No overt psychosis, mental disability, or incompetence
- No diabetes mellitus
- No other prior malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- No hypersensitivity or allergic reaction to paclitaxel
- See Disease Characteristics
- No other concurrent anti-cancer biologic therapy
- See Disease Characteristics
- No concurrent anti-cancer chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- No sole indicator lesion within the previously irradiated port
- No concurrent anti-cancer radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior major surgery and recovered
- At least 1 year since prior bypass surgery for atherosclerotic coronary artery disease
- No concurrent surgery for cancer
- No other investigational drugs (e.g., analgesics or antiemetics) for at least 28 days prior to and after study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of SU5416 (NSC 696819) for Patients With Progressive Metastatic Renal Cancer Failing Prior Biologic Therapy or 5-Fluorouracil Containing Regimens
Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic kidney cancer that has not responded to previous therapy with interleukin-2. SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor
Read the detailed description
OBJECTIVES:
- Determine the clinical activity of SU5416 in patients with progressive metastatic renal cancer failing prior biologic therapy or fluorouracil-containing regimens.
II. Determine the changes in tumor perfusion in patients treated with this regimen.
III. Determine the time to progression and survival in patients treated with this regimen.
OUTLINE:
Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues every 6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive an additional 6 months of therapy after achieving CR.
Patients are followed every 3 months.
- Being tested
- semaxanib
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaxanibDrug
Also called semoxind, SU5416, Sugen 5416
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (semaxanib) | Experimental | Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues every 6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with CR receive an additional 6 months of therapy after achieving CR. Receives: Drug: semaxanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of progression-free events
Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.
Measured: 6 months
Objective response rate
Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.
Measured: Up to 3 years
Secondary outcomes (4)
Survival
Analyzed using Kaplan Meier curves and Cox proportional hazards models.
Measured: Up to 3 years
Time to disease progression
Analyzed using Kaplan Meier curves and Cox proportional hazards.
Measured: Up to 3 years
Time to treatment failure
Analyzed using Kaplan Meier curves and Cox proportional hazards.
Measured: Up to 3 years
Duration of response
Analyzed using Kaplan Meier curves and Cox proportional hazards.
Measured: Up to 3 years
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 startDec 2000
- Primary completionJun 2003
Why it stopped: Administratively complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Arlene Siefker-Radtke, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00009919
- Sponsor's protocol ID
- NCI-2012-02373
- Other IDs
- ID99-291, N01CM17003, CDR0000068424
- Status last verified
- Jan 2013
- First submitted
- 2 Feb 2001
- Last updated
- 23 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of SU5416 (NSC 696819) for Patients With Progressive Metastatic Renal Cancer Failing Prior Biologic Therapy or 5-Fluorouracil Containing Regimens
- ClinicalTrials.gov ID
- NCT00009919
- Acronym / sponsor ID
- NCI-2012-02373
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively complete.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2000
- Primary completion
- Jun 2003 (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.
Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic kidney cancer that has not responded to previous therapy with interleukin-2. SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor
Detailed description
OBJECTIVES:
- Determine the clinical activity of SU5416 in patients with progressive metastatic renal cancer failing prior biologic therapy or fluorouracil-containing regimens.
II. Determine the changes in tumor perfusion in patients treated with this regimen.
III. Determine the time to progression and survival in patients treated with this regimen.
OUTLINE:
Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues every 6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive an additional 6 months of therapy after achieving CR.
Patients are followed every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (semaxanib) | Experimental | Drug: semaxanibPatients receive SU5416 IV over 1 hour twice weekly. Treatment continues every 6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with CR receive an additional 6 months of therapy after achieving CR. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (52 listed)
- Histologically confirmed metastatic renal cell carcinoma
- Prior removal of primary tumors
- Bidimensionally measurable disease
- Progressive disease following no more than 2 prior biologic therapy (e.g.,interleukin-2, interferon alfa, vaccine, or dendritic cell therapy) orfluorouracil-containing (single-agent or in combination therapy) regimens
- No known history of CNS metastasis unless all of the following are true:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| semaxanibAlso: semoxind, SU5416, Sugen 5416Given IV | Drug | Treatment (semaxanib) |
Primary outcome
Rate of progression-free events
Time frame: 6 months
Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.
Objective response rate
Time frame: Up to 3 years
Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.
4 secondary outcomes
Survival
Time frame: Up to 3 years
Time to disease progression
Time frame: Up to 3 years
Time to treatment failure
Time frame: Up to 3 years
Duration of response
Time frame: Up to 3 years
Results and safety
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
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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.
Arlene Siefker-Radtke principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing semaxanib in people with Recurrent Renal Cell Cancer and Stage IV Renal Cell Cancer, run by National Cancer Institute (NCI) at 1 site 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 52 inclusion and 0 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: stopped early, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Administratively complete.). Results are not available in the source record.
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?
Rate of progression-free events (time frame: 6 months). The study lists 2 primary outcomes in all. 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 23 Jan 2013.