SarcomaPhase 2NCT00837148
Sorafenib and Dacarbazine in Soft Tissue Sarcoma
A Phase 2 study testing Sorafenib and Dacarbazine in people with Sarcoma and Synovial Sarcoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to find out what effects, good and/or bad, the combination of sorafenib and dacarbazine has on sarcoma. Recurrent sarcoma is difficult to treat. Standard chemotherapy drugs can be toxic, and the length of benefit is usually short. As a result, we need new treatments for sarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Synovial Sarcoma, Leiomyosarcoma
- What is being tested?
- Sorafenib and Dacarbazine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Nov 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must have histologically or cytologically confirmed leiomyosarcoma, synovial sarcoma or malignant peripheral nerve sheath tumor (MPNST).
- Patients with metastatic, locally advanced, unresectable or locally recurrent disease.
- Zero to two prior chemotherapy regimens including neoadjuvant or adjuvant therapy.
- Measurable disease as defined by RECIST 1.1.
- Age ≥ 18.
- Karnofsky performance status of 50%-100%.
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- Adequate bone marrow, liver and renal function as assessed by the following:
- Hemoglobin ≥ 8.5 g/dl Absolute neutrophil count (ANC) ≥ 1,500/mm3 Platelet count ≥ 75,000/mm3 Total bilirubin < or = to 1.5 times ULN ALT and AST < or = to 2.5 times the ULN ( < or = to 5 x ULN for patients with liver involvement) Creatinine < or = to 1.5 times ULN
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
- Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Patients should use adequate birth control for at least three months after the last administration of sorafenib.
- Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
- INR < 1.5 or a PT/PTT within normal limits if not on anticoagulation. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable.
Who cannot join
- Prior therapy with dacarbazine, sorafenib or other antiangiogenic agents.
- Chemotherapy within 3 weeks or radiotherapy within 2 weeks of first day of protocol therapy.
- More than two prior chemotherapy regimens.
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
- Pregnancy or nursing.
- Social situation or psychiatric illness that would limit compliance with study requirements.
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- Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg for more than 24 hours, despite optimal medical management.
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- Active clinically serious infection > CTCAE Grade 2.
- Thrombotic or embolic events such as a cerebrovascular accident, transient ischemic attack or myocardial infarction within the past 6 months, or deep venous thrombosis or pulmonary embolism within two months.
- Pulmonary hemorrhage/bleeding event > or = to CTCAE Grade 2 within 4 weeks of first dose of study drug.
- Any other hemorrhage/bleeding event > or = to CTCAE Grade 3 within 4 weeks of first dose of study drug.
- Serious non-healing wound, ulcer, or bone fracture.
- Evidence or history of bleeding diathesis or coagulopathy.
- Any history of grade 4 thrombocytopenia (Plt <25,000), Grade 3 thrombocytopenia (Plt <50,000, >25,000) lasting 7 days or longer, or history of platelet transfusions for chemotherapy induced thrombocytopenia
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
- Use of St. John's Wort or rifampin (rifampicin).
- Known or suspected allergy to sorafenib or any agent given in the course of this trial.
- Any condition that impairs patient's ability to swallow pills.
- Any malabsorption problem that in the opinion of the investigator would interfere with the patients ability to tolerate oral sorafenib.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Phase II Trial of Sorafenib and Dacarbazine in Soft Tissue Sarcoma
The purpose of this study is to find out what effects, good and/or bad, the combination of sorafenib and dacarbazine has on sarcoma. Recurrent sarcoma is difficult to treat. Standard chemotherapy drugs can be toxic, and the length of benefit is usually short. As a result, we need new treatments for sarcoma. Sorafenib is a new type of "targeted" chemotherapy that attacks specific proteins (including "raf" and "VEGF receptor") in cells. We hope that by blocking these proteins we can cause the tumor to shrink. Sorafenib is also known as BAY 43-9006 and by the trade name Nexavar®. The FDA approved sorafenib in December of 2005 to treat patients with kidney cancer and in November of 2007 to treat patients with liver cancer. This drug is not approved by the U.S. Food and Drug Administration (FDA) or any other licensing authority for the treatment of sarcoma and is therefore considered to be experimental in this setting.
- Being tested
- Sorafenib and Dacarbazine
- Keywords
- Sarcoma, Bone, BAY 43-9006 (SORAFENIB), DACARBAZINE, 08-068
- Medical subject headings
- Sarcoma, Sarcoma, Synovial, Leiomyosarcoma, Neurofibrosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib and DacarbazineDrug
Treatment will be administered on an outpatient basis. Sorafenib is supplied as 200-mg tablets. The starting dose of sorafenib will be 400 mg PO twice daily (every 12 hours) continuously. There is no planned treatment interruption between cycles.
All patients will receive dacarbazine as an open-label dose of 850 mg/m2 by IV infusion over 60 minutes, starting on Week 1 and repeated every 3 weeks until disease progression or intolerance.
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib and Dacarbazine | Experimental | This study is an open label, single arm, Simon two stage, phase 2 trial of continuous, daily oral sorafenib, with intravenous dacarbazine administered every three weeks for patients with synovial sarcoma, leiomyosarcoma and malignant peripheral nerve sheath tumor. Receives: Drug: Sorafenib and Dacarbazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Objective Response
Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Measured: at 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- William Tap, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837148
- Sponsor's protocol ID
- 08-068
- Status last verified
- Oct 2015
- First submitted
- 4 Feb 2009
- Last updated
- 20 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Sorafenib and Dacarbazine in Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT00837148
- Acronym / sponsor ID
- 08-068
- Keywords
- Sarcoma, Bone, BAY 43-9006 (SORAFENIB), DACARBAZINE, 08-068
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Feb 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Posted 20 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out what effects, good and/or bad, the combination of sorafenib and dacarbazine has on sarcoma. Recurrent sarcoma is difficult to treat. Standard chemotherapy drugs can be toxic, and the length of benefit is usually short. As a result, we need new treatments for sarcoma. Sorafenib is a new type of "targeted" chemotherapy that attacks specific proteins (including "raf" and "VEGF receptor") in cells. We hope that by blocking these proteins we can cause the tumor to shrink. Sorafenib is also known as BAY 43-9006 and by the trade name Nexavar®. The FDA approved sorafenib in December of 2005 to treat patients with kidney cancer and in November of 2007 to treat patients with liver cancer. This drug is not approved by the U.S. Food and Drug Administration (FDA) or any other licensing authority for the treatment of sarcoma and is therefore considered to be experimental in this setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib and Dacarbazine | Experimental | Drug: Sorafenib and DacarbazineThis study is an open label, single arm, Simon two stage, phase 2 trial of continuous, daily oral sorafenib, with intravenous dacarbazine administered every three weeks for patients with synovial sarcoma, leiomyosarcoma and malignant peripheral nerve sheath tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have histologically or cytologically confirmed leiomyosarcoma, synovial sarcoma or malignant peripheral nerve sheath tumor (MPNST).
- Patients with metastatic, locally advanced, unresectable or locally recurrent disease.
- Zero to two prior chemotherapy regimens including neoadjuvant or adjuvant therapy.
- Measurable disease as defined by RECIST 1.1.
- Age ≥ 18.
Key exclusion criteria (22 listed)
- Prior therapy with dacarbazine, sorafenib or other antiangiogenic agents.
- Chemotherapy within 3 weeks or radiotherapy within 2 weeks of first day of protocol therapy.
- More than two prior chemotherapy regimens.
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
- Pregnancy or nursing.
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 |
|---|---|---|
| Sorafenib and DacarbazineTreatment will be administered on an outpatient basis. Sorafenib is supplied as 200-mg tablets. The starting dose of sorafenib will be 400 mg PO twice daily (every 12 hours) continuously. There is no planned treatment interruption between cycles. All patients will receive dacarbazine as an open-label dose of 850 mg/m2 by IV infusion over 60 minutes, starting on Week 1 and repeated every 3 weeks until disease progression or intolerance. | Drug | Sorafenib and Dacarbazine |
Primary outcome
Overall Objective Response
Time frame: at 18 weeks
Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
William Tap, MD principal investigator
Memorial Sloan Kettering 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 Sorafenib and Dacarbazine in people with Sarcoma and Synovial Sarcoma, run by Memorial Sloan Kettering Cancer Center 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 12 inclusion and 22 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 20 Nov 2015. 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?
Yes. Results are posted in the registry (first posted 20 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Objective Response (time frame: at 18 weeks). 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 20 Nov 2015; AzTrials last refreshed its copy on 31 Oct 2026.