SarcomaPhase 2NCT00880542
Sorafenib and Ifosfamide in Treating Patients With High-Grade Soft Tissue Sarcoma or Bone Sarcoma That Can Be Removed by Surgery
A Phase 2 study testing sorafenib and Ifosfamide in people with Sarcoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- sorafenib and Ifosfamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Nov 2010
- 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
- Pathologically confirmed high grade sarcoma of the soft tissue or bone
- participants Identified as a proper candidate for ifosfamide-based neoadjuvant therapy
- candidates must have operable disease for which a resection is planned
- ECOG performance status 0-1
- Hemoglobin ≥ 9.0 g/dL
- ANC ≥ 1,500/mm³
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- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement)
- INR < 1.5 or PT/PTT normal.Concurrent anticoagulation therapy with warfarin or heparin allowed
- Creatinine ≤ 1.5 times ULN
- women of childbearing potential must have negative pregnancy test performed within 7 days prior to start of treatment.
- Fertile patients must use effective contraception during and for ≥ 2 weeks after completion of study therapy.
- A signed informed consent must be obtained prior to any study specific procedures.
Who cannot join
- known HIV infection
- chronic hepatitis B or C infection
- clinically active serious infection > CTCAE grade 2
- NYHA class III or IV congestive heart failure
- unstable angina (i.e., anginal symptoms at rest) or new onset angina within the past 3 months
- myocardial infarction within the past 6 months
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- cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 90 mm Hg) despite optimal medical management
- thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
- pulmonary hemorrhage or bleeding event ≥ CTCAE grade 2 within the past 4 weeks
- other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks
- Any condition that would impair the ability to swallow whole pills
- malabsorption problem
- Any known severe hypersensitivity to sorafenib tosylate or any of its excipients
- known or suspected allergy to sorafenib tosylate or any agent given in this study
- serious nonhealing wound, ulcer, or bone fracture
- evidence or history of bleeding diathesis or coagulopathy
- significant traumatic injury within the past 4 weeks
- major surgery or open biopsy within 4 weeks of starting treatment
- Concomitant St. John's wort or rifampin
- KNown brain metastases. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastases.
- any condition that impairs patients' ability to swallow pills
- any malabsorption problem
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
About this study
Official title: A Phase II Study of Sorafenib and Ifosfamide as a Treatment for Patients With Sarcoma
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with ifosfamide may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with ifosfamide and to see how well it works in treating patients with high-grade soft tissue sarcoma or bone sarcoma that can be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- Assess the safety, toxicity, and efficacy of neoadjuvant sorafenib tosylate and ifosfamide in patients with resectable high-grade soft tissue or bone sarcoma.
Secondary
- Assess the long-term efficacy or impact of therapy in these patients, in terms of the duration of local recurrence-free survival, distant recurrence-free survival, and disease-specific survival.
OUTLINE:
- Neoadjuvant therapy: Patients receive oral sorafenib tosylate twice daily on days 1-14 in course 1. Patients then receive oral sorafenib tosylate twice daily on days 1-28 and ifosfamide IV continuously on days 1-7 in courses 2 and 3. Treatment repeats every 14-28 days* for 3 courses.
NOTE: *Course 1 is 14 days in duration; courses 2 and 3 are 28 days in duration.
- Surgery: At least 1 week after the completion of neoadjuvant therapy, patients undergo surgery.
- Adjuvant therapy: Beginning ≥ 3 weeks after surgery, patients who respond to neoadjuvant therapy receive oral sorafenib twice daily for 6 months. Patients also receive 2 courses of ifosfamide as in courses 2 and 3 of neoadjuvant therapy.
- Conditions
- Sarcoma
- Being tested
- sorafenib, Ifosfamide
- Keywords
- localized osteosarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sorafenibDrug
Patients with sarcoma who have resectable disease will be treated with neoadjuvant sorafenib and ifosfamide. PET/CT will be used to assess the metabolic and radiographic response to therapy.
IfosfamideDrug
Patients with sarcoma who have resectable disease will be treated with neoadjuvant ifosfamide and sorafenib. PET/CT will be used to assess the metabolic and radiographic response to therapy.
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib + Ifosfamide | Experimental | * Neoadjuvant therapy: Patients receive oral sorafenib tosylate twice daily on days 1-14 in course 1. Patients then receive oral sorafenib tosylate twice daily on days 1-28 and ifosfamide IV continuously on days 1-7 in courses 2 and 3. Treatment repeats every 14-28 days* for 3 courses.
NOTE: *Course 1 is 14 days in duration; courses 2 and 3 are 28 days in duration.
* Surgery: At least 1 week after the completion of neoadjuvant therapy, patients undergo surgery.
* Adjuvant therapy: Beginning ≥ 3 weeks after surgery, patients who respond to neoadjuvant therapy receive oral sorafenib twice daily for 6 months. Patients also receive 2 courses of ifosfamide as in courses 2 and 3 of neoadjuvant therapy. Receives: Drug: sorafenib; Drug: Ifosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using PET/CT Scan to Measure Safety, Toxicity, and Efficacy of Neoadjuvant Sorafenib Tosylate and Ifosfamide in Patients With Resectable High-grade Soft Tissue or Bone Sarcoma.
After cycle 1, a limited PET/CT scan of the affected site will be performed to assess response to sorafenib treatment alone. After cycle 3, prior to surgery, a limited PET/CT scan of the affected site will be performed to assess response to the combination sorafenib and ifosfamide treatment.
Measured: Participants were followed for duration of study, an average of 1 year.
Secondary outcomes (1)
Local and Distant Recurrence-free Survival
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startAug 2008
- Primary completionNov 2010
Why it stopped: The study lost funding.
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 Jonsson Comprehensive 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Tap, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880542
- Sponsor's protocol ID
- CDR0000633030
- Other IDs
- UCLA-0704086, BAYER-UCLA-0704086, ONYX-UCLA-0704086
- Status last verified
- Jul 2012
- First submitted
- 10 Apr 2009
- Last updated
- 10 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Sorafenib and Ifosfamide as a Treatment for Patients With Sarcoma
- ClinicalTrials.gov ID
- NCT00880542
- Acronym / sponsor ID
- CDR0000633030
- Conditions
- Sarcoma
- Keywords
- localized osteosarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study lost funding.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Nov 2010 (actual)
- First posted
- 13 Apr 2009 (estimated)
- Results
- Posted 10 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with ifosfamide may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with ifosfamide and to see how well it works in treating patients with high-grade soft tissue sarcoma or bone sarcoma that can be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- Assess the safety, toxicity, and efficacy of neoadjuvant sorafenib tosylate and ifosfamide in patients with resectable high-grade soft tissue or bone sarcoma.
Secondary
- Assess the long-term efficacy or impact of therapy in these patients, in terms of the duration of local recurrence-free survival, distant recurrence-free survival, and disease-specific survival.
OUTLINE:
- Neoadjuvant therapy: Patients receive oral sorafenib tosylate twice daily on days 1-14 in course 1. Patients then receive oral sorafenib tosylate twice daily on days 1-28 and ifosfamide IV continuously on days 1-7 in courses 2 and 3. Treatment repeats every 14-28 days* for 3 courses.
NOTE: *Course 1 is 14 days in duration; courses 2 and 3 are 28 days in duration.
- Surgery: At least 1 week after the completion of neoadjuvant therapy, patients undergo surgery.
- Adjuvant therapy: Beginning ≥ 3 weeks after surgery, patients who respond to neoadjuvant therapy receive oral sorafenib twice daily for 6 months. Patients also receive 2 courses of ifosfamide as in courses 2 and 3 of neoadjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib + Ifosfamide | Experimental | Drug: sorafenib, Drug: Ifosfamide* Neoadjuvant therapy: Patients receive oral sorafenib tosylate twice daily on days 1-14 in course 1. Patients then receive oral sorafenib tosylate twice daily on days 1-28 and ifosfamide IV continuously on days 1-7 in courses 2 and 3. Treatment repeats every 14-28 days* for 3 courses. NOTE: *Course 1 is 14 days in duration; courses 2 and 3 are 28 days in duration. * Surgery: At least 1 week after the completion of neoadjuvant therapy, patients undergo surgery. * Adjuvant therapy: Beginning ≥ 3 weeks after surgery, patients who respond to neoadjuvant therapy receive oral sorafenib twice daily for 6 months. Patients also receive 2 courses of ifosfamide as in courses 2 and 3 of neoadjuvant therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Pathologically confirmed high grade sarcoma of the soft tissue or bone
- participants Identified as a proper candidate for ifosfamide-based neoadjuvant therapy
- candidates must have operable disease for which a resection is planned
- ECOG performance status 0-1
- Hemoglobin ≥ 9.0 g/dL
Key exclusion criteria (23 listed)
- known HIV infection
- chronic hepatitis B or C infection
- clinically active serious infection > CTCAE grade 2
- NYHA class III or IV congestive heart failure
- unstable angina (i.e., anginal symptoms at rest) or new onset angina within the past 3 months
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 |
|---|---|---|
| sorafenibPatients with sarcoma who have resectable disease will be treated with neoadjuvant sorafenib and ifosfamide. PET/CT will be used to assess the metabolic and radiographic response to therapy. | Drug | Sorafenib + Ifosfamide |
| IfosfamidePatients with sarcoma who have resectable disease will be treated with neoadjuvant ifosfamide and sorafenib. PET/CT will be used to assess the metabolic and radiographic response to therapy. | Drug | Sorafenib + Ifosfamide |
Primary outcome
Using PET/CT Scan to Measure Safety, Toxicity, and Efficacy of Neoadjuvant Sorafenib Tosylate and Ifosfamide in Patients With Resectable High-grade Soft Tissue or Bone Sarcoma.
Time frame: Participants were followed for duration of study, an average of 1 year.
After cycle 1, a limited PET/CT scan of the affected site will be performed to assess response to sorafenib treatment alone. After cycle 3, prior to surgery, a limited PET/CT scan of the affected site will be performed to assess response to the combination sorafenib and ifosfamide treatment.
1 secondary outcome
Local and Distant Recurrence-free Survival
Time frame: conclusion of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
Jonsson Comprehensive 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 Ifosfamide in people with Sarcoma, run by Jonsson Comprehensive 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 14 inclusion and 23 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 10 Aug 2020. 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 10 May 2011). 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?
Using PET/CT Scan to Measure Safety, Toxicity, and Efficacy of Neoadjuvant Sorafenib Tosylate and Ifosfamide in Patients With Resectable High-grade Soft Tissue or Bone Sarcoma. (time frame: Participants were followed for duration of study, an average of 1 year.). 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 10 Aug 2020; AzTrials last refreshed its copy on 7 Nov 2026.