Stage III Adult Soft Tissue SarcomaPhase 1/2NCT01719302
Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma
A Phase 1/2 study testing Gemcitabine, Docetaxel and Pazopanib in people with Stage III Adult Soft Tissue Sarcoma, run by University of Vermont at 1 site in United States.
Trial summary
Chemotherapy treatment with docetaxel and gemcitabine is a standard treatment for patients with soft tissue sarcoma. This study is designed to explore whether the addition of tyrosine kinase inhibitor pazopanib enhances the anticancer effect of the chemotherapy drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Adult Soft Tissue Sarcoma
- What is being tested?
- Gemcitabine, Docetaxel and Pazopanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Apr 2015
- Phase
- Phase 1/2
- 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
Who may be able to join
- 18 years or older
- chemotherapy naive, histologically high grade soft tissue sarcoma that is considered to be operable
- tumor greater than 5 cm in longest dimension
- life expectancy of at least 6 months
- Zubrod performance status of 0-2
- signed informed consent
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- adequate bone marrow function defined by:
- absolute peripheral granulocyte count of >1500 cells/mm^3
- hemoglobin >8.0 g/dl
- platelet count >100,000/mm^3
- absence of a regular red blood cell transfusion requirement
- adequate hepatic function defined by:
- total bilirubin <1.5 x upper limit of normal (ULN)
- AST, ALT and alkaline phosphatase all not more than 2.5 x ULN
- adequate renal function defined by:
- 1. serum creatinine <1.5 x ULN
- negative pregnancy test for women of child bearing potential
- willingness to use effective contraception while on treatment and for 3 months thereafter
Who cannot join
- Multiple metastases (patients with 5 or fewer oligometastases that could be resectable are eligible)
- Pregnant women or nursing mothers
- concurrent chemotherapy or radiation therapy
- severe medical problems (at the discretion of the investigator)
- history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- symptomatic brain metastases
- cirrhosis
- dermatofibrosarcoma protuberans (DFSP), embryonal rhabdomyosarcoma or alveolar soft part sarcoma (ASPS)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fletcher Allen Health Care
Burlington, Vermont, 05401
About this study
Official title: Phase I/II Study of the Combination of Docetaxel, Gemcitabine and Pazopanib for Neoadjuvant Treatment of Patients With Operable Soft Tissue Sarcoma
Chemotherapy treatment with docetaxel and gemcitabine is a standard treatment for patients with soft tissue sarcoma. This study is designed to explore whether the addition of tyrosine kinase inhibitor pazopanib enhances the anticancer effect of the chemotherapy drugs.
The Phase I component of this study is designed to determine the maximum tolerated dose of pazopanib when given with docetaxel and gemcitabine. The Phase II component is designed to determine the overall response rate of the combination of docetaxel, gemcitabine and pazopanib prior to surgical resection in patients with soft tissue sarcoma.
- Conditions
- Stage III Adult Soft Tissue Sarcoma
- Being tested
- Gemcitabine, Docetaxel, Pazopanib
- Keywords
- Soft tissue sarcoma, gemcitabine, docetaxel, pazopanib
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
1500 mg/m^2 given days 1 and 15 of every 28 day cycle for a total of 4 cycles
DocetaxelDrug
Also called Taxotere
50 mg/m^2 on days 1 and 15 of each 28 day cycle for a total of 4 cycles
PazopanibDrug
Also called Votrient
Starting dose of 400 mg/day starting 72 hours after docetaxel/gemcitabine administration for 10 days (days 4-13 and 18-27) of each 28 day cycle for a total of 4 cycles. Dose will be increased by 200 mg/day for each cohort until the maximum tolerated dose is identified.
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 | Experimental | Not described Receives: Drug: Gemcitabine; Drug: Docetaxel; Drug: Pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Measured: 1 cycle (28 days)
Secondary outcomes (1)
Overall response rate
Measured: 4 cycles (112 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Adult Soft Tissue SarcomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Claire Verschraegen, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719302
- Sponsor's protocol ID
- VCC 1202
- Status last verified
- Jun 2016
- First submitted
- 29 Oct 2012
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of the Combination of Docetaxel, Gemcitabine and Pazopanib for Neoadjuvant Treatment of Patients With Operable Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT01719302
- Acronym / sponsor ID
- VCC 1202
- Conditions
- Stage III Adult Soft Tissue Sarcoma
- Keywords
- Soft tissue sarcoma, gemcitabine, docetaxel, pazopanib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Oct 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 Nov 2012 (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.
Chemotherapy treatment with docetaxel and gemcitabine is a standard treatment for patients with soft tissue sarcoma. This study is designed to explore whether the addition of tyrosine kinase inhibitor pazopanib enhances the anticancer effect of the chemotherapy drugs.
The Phase I component of this study is designed to determine the maximum tolerated dose of pazopanib when given with docetaxel and gemcitabine. The Phase II component is designed to determine the overall response rate of the combination of docetaxel, gemcitabine and pazopanib prior to surgical resection in patients with soft tissue sarcoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort 1 | Experimental | Drug: Gemcitabine, Drug: Docetaxel, Drug: Pazopanib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 18 years or older
- chemotherapy naive, histologically high grade soft tissue sarcoma that is considered to be operable
- tumor greater than 5 cm in longest dimension
- life expectancy of at least 6 months
- Zubrod performance status of 0-2
Key exclusion criteria (8 listed)
- Multiple metastases (patients with 5 or fewer oligometastases that could be resectable are eligible)
- Pregnant women or nursing mothers
- concurrent chemotherapy or radiation therapy
- severe medical problems (at the discretion of the investigator)
- history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
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 |
|---|---|---|
| GemcitabineAlso: Gemzar1500 mg/m^2 given days 1 and 15 of every 28 day cycle for a total of 4 cycles | Drug | cohort 1 |
| DocetaxelAlso: Taxotere50 mg/m^2 on days 1 and 15 of each 28 day cycle for a total of 4 cycles | Drug | cohort 1 |
| PazopanibAlso: VotrientStarting dose of 400 mg/day starting 72 hours after docetaxel/gemcitabine administration for 10 days (days 4-13 and 18-27) of each 28 day cycle for a total of 4 cycles. Dose will be increased by 200 mg/day for each cohort until the maximum tolerated dose is identified. | Drug | cohort 1 |
Primary outcome
Maximum Tolerated Dose
Time frame: 1 cycle (28 days)
1 secondary outcome
Overall response rate
Time frame: 4 cycles (112 days)
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 16 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gemcitabine, Docetaxel and Pazopanib in people with Stage III Adult Soft Tissue Sarcoma, run by University of Vermont 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 18 inclusion and 8 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 16 Jun 2016. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Maximum Tolerated Dose (time frame: 1 cycle (28 days)). 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 16 Jun 2016.