Gastrointestinal Stromal TumorPhase 2NCT00005862
SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas
A Phase 2 study testing semaxanib in people with Gastrointestinal Stromal Tumor and Sarcoma, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
Phase II trial to study the effectiveness of SU5416 in treating patients who have advanced, metastatic, or recurrent soft tissue sarcomas. SU5416 may stop the growth of soft tissue sarcomas by stopping blood flow to the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumor, Sarcoma
- 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
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2000to Jul 2004
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced, metastatic, recurrent, or unresectable soft tissue sarcoma or gastrointestinal stromal tumor
- Measurable disease defined as lesions that can be measured in at least one dimension as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
- Must have received prior chemotherapy with no response or progression after initial response
- Evidence of disease progression in past 3 months
- No CNS metastases or primary brain tumors
PATIENT CHARACTERISTICS:
- Age: 18 and over
- Performance status: ECOG 0-1
- Life expectancy: At least 12 weeks
- WBC greater than 2,000/mm3
- Platelet count greater than 100,000/mm3
- Fibrin split products no greater than 0.001 mg
- Fibrinogen greater than 200 mg/dL
- Bilirubin no greater than upper limit of normal (ULN)
- AST/ALT less than 1.5 times ULN
- PT/PTT less than 1.25 times ULN
- Creatinine no greater than 1.5 mg/dL
- At least 1 year since bypass surgery for atherosclerotic coronary artery disease
- No uncompensated coronary artery disease
- No history of myocardial infarction or unstable/severe angina in past 6 months
- No severe peripheral vascular disease
- No history of deep venous or arterial thrombosis in past 3 months
- No history of pulmonary embolism in past 3 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No diabetes mellitus
- No history of bleeding diathesis
- No known active retroviral disease
- No AIDS-associated Kaposi's sarcoma
- No history of allergic reaction to Cremophor or paclitaxel
- No uncontrolled illness or psychiatric disorder that would preclude study
PRIOR CONCURRENT THERAPY:
- No concurrent immunotherapy
- At least 3 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas)
- No concurrent chemotherapy
- At least 3 weeks since prior radiotherapy
- No concurrent radiotherapy
- Greater than 2 weeks since prior minor surgery (greater than 4 weeks since major surgery)
- No concurrent antiinflammatory drugs
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Trial of SU5416 (NSC #696819) in Previously Treated Patients With Advanced, Metastatic and/or Locally Recurrent Soft Tissue Sarcomas
Phase II trial to study the effectiveness of SU5416 in treating patients who have advanced, metastatic, or recurrent soft tissue sarcomas. SU5416 may stop the growth of soft tissue sarcomas by stopping blood flow to the tumor.
Read the detailed description
OBJECTIVES:
- Determine the response rate, response duration, and overall survival in patients with advanced, metastatic, or recurrent soft tissue sarcoma or gastrointestinal stromal tumor when treated with SU5416.
II. Determine the safety of SU5416 in these patients.
OUTLINE: This is a multicenter study.
Patients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 3 months and then every 3 months for 1 year.
- Conditions
- Gastrointestinal Stromal Tumor, Sarcoma
- Being tested
- semaxanib
- Keywords
- stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, gastrointestinal stromal tumor, stage IV adult soft tissue sarcoma
- Medical subject headings
- Gastrointestinal Stromal Tumors, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaxanibDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | atients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: semaxanib |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2004 (estimated)
- Study startOct 2000
- Primary completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- George D. Demetri, MD, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005862
- Sponsor's protocol ID
- CDR0000067893
- Other IDs
- DFCI-00002, NCI-330
- Status last verified
- Apr 2002
- First submitted
- 2 Jun 2000
- Last updated
- 11 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of SU5416 (NSC #696819) in Previously Treated Patients With Advanced, Metastatic and/or Locally Recurrent Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT00005862
- Acronym / sponsor ID
- CDR0000067893
- Conditions
- Gastrointestinal Stromal Tumor, Sarcoma
- Keywords
- stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, gastrointestinal stromal tumor, stage IV adult soft tissue sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 2000
- Primary completion
- Jul 2004 (actual)
- First posted
- 12 Feb 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 advanced, metastatic, or recurrent soft tissue sarcomas. SU5416 may stop the growth of soft tissue sarcomas by stopping blood flow to the tumor.
Detailed description
OBJECTIVES:
- Determine the response rate, response duration, and overall survival in patients with advanced, metastatic, or recurrent soft tissue sarcoma or gastrointestinal stromal tumor when treated with SU5416.
II. Determine the safety of SU5416 in these patients.
OUTLINE: This is a multicenter study.
Patients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 3 months and then every 3 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: semaxanibatients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| semaxanib | Drug | Arm I |
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 11 Feb 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.
George D. Demetri, MD study chair
Dana-Farber Cancer Institute
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 semaxanib in people with Gastrointestinal Stromal Tumor and Sarcoma, run by National Cancer Institute (NCI) 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 11 Feb 2013. 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 11 Feb 2013.