SarcomaPhase 1NCT00276055
Phase IB Study of Gemcitabine, Docetaxel and Bevacizumab in Patients With Soft Tissue Sarcoma
A Phase 1 study testing Gemcitabine, Docetaxel and Bevacizumab in people with Sarcoma, run by New Mexico Cancer Research Alliance at 4 sites in United States.
Trial summary
1.1 To determine the recommended phase II dose for gemcitabine in combination with a fixed dose of docetaxel and bevacizumab. 1.2 To determine the efficacy of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma 1.3 To determine the toxicity profile of the combination of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Gemcitabine, Docetaxel and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2005to Nov 2010
- Phase
- Phase 1
- 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
- All patients, 18 years of age or older, with chemotherapy naive soft tissue sarcoma are eligible if there is measurable disease Prior surgery or radiotherapy for the primary tumor is allowed but needs to have been completed at least 2 weeks from entry, and patient should have completely recovered from the procedures.
- Patients must have a life expectancy of at least 12 weeks.
- Patients must have a Zubrod performance status of 0-2.
- Patients must sign an informed consent.
- Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 and absence of a regular red blood cell transfusion requirement.
- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine < 1.5 x upper limit of normal.
Who cannot join
- Patients with symptomatic brain metastases are excluded from this study.
- Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
- Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
- Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hematology Oncology Associates
Albuquerque, New Mexico, 87102-3661
University of New Mexico
Albuquerque, New Mexico, 87131
St. Vincent Regional Medical Center
Santa Fe, New Mexico, 87505
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87508
About this study
1.1 To determine the recommended phase II dose for gemcitabine in combination with a fixed dose of docetaxel and bevacizumab.
1.2 To determine the efficacy of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma 1.3 To determine the toxicity profile of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma
Read the detailed description
Because the combination of gemcitabine and docetaxel has shown impressive activity in soft tissue sarcoma, we hypothesize that the addition of an antiangiogenesis agent (bevacizumab) would enhance the anticancer activity, as shown in other tumor types.
- Conditions
- Sarcoma
- Being tested
- Gemcitabine, Docetaxel and Bevacizumab
- Keywords
- Soft Tissue Sarcoma, Phase I, Gemcitabine, Docetaxel, Bevacizumab, vascular endothelial growth factor
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine, Docetaxel and BevacizumabDrug
Also called Taxotere, Gemzar, Avastin
During the treatment phase, pts. will receive the drug combination of gemcitabine, docetaxel, and bevacizumab every 2 weeks for a period of 4 weeks. This 4-week period is called a cycle of treatment. The treatment consists of receiving docetaxel IV over a 60-minute period and gemcitabine IV over a 30-minute period. Pts. will then receive bevacizumab IV over a 30-minute period. Pts. will receive this treatment once every 2 weeks. Pts. will receive at least 2 cycles of treatment unless you have progression of your disease or unmanageable side effects. As long as the size of pts.'s tumor stays the same or gets smaller, pts may continue receiving treatment
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 1000mg/m2 gemcitabine Receives: Drug: Gemcitabine, Docetaxel and Bevacizumab |
| Cohort 2 | Experimental | 1250 mg/m2 gemcitabine Receives: Drug: Gemcitabine, Docetaxel and Bevacizumab |
| Cohort 3 | Experimental | 1500 mg/m2 gemcitabine Receives: Drug: Gemcitabine, Docetaxel and Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (complete and partial responses).
Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). ORR is the sum of the percentages of patients achieving complete and partial responses
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startNov 2005
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Verschraegen, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276055
- Sponsor's protocol ID
- INST 0509C
- Status last verified
- Jun 2015
- First submitted
- 11 Jan 2006
- Last updated
- 19 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IB Study of Gemcitabine, Docetaxel and Bevacizumab in Patients With Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT00276055
- Acronym / sponsor ID
- INST 0509C
- Conditions
- Sarcoma
- Keywords
- Soft Tissue Sarcoma, Phase I, Gemcitabine, Docetaxel, Bevacizumab, vascular endothelial growth factor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 12 Jan 2006 (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.
1.1 To determine the recommended phase II dose for gemcitabine in combination with a fixed dose of docetaxel and bevacizumab.
1.2 To determine the efficacy of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma 1.3 To determine the toxicity profile of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma
Detailed description
Because the combination of gemcitabine and docetaxel has shown impressive activity in soft tissue sarcoma, we hypothesize that the addition of an antiangiogenesis agent (bevacizumab) would enhance the anticancer activity, as shown in other tumor types.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Gemcitabine, Docetaxel and Bevacizumab1000mg/m2 gemcitabine |
| Cohort 2 | Experimental | Drug: Gemcitabine, Docetaxel and Bevacizumab1250 mg/m2 gemcitabine |
| Cohort 3 | Experimental | Drug: Gemcitabine, Docetaxel and Bevacizumab1500 mg/m2 gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients, 18 years of age or older, with chemotherapy naive soft tissue sarcoma are eligible if there is measurable disease Prior surgery or radiotherapy for the primary tumor is allowed but needs to have been completed at least 2 weeks from entry, and patient should have completely recovered from the procedures.
- Patients must have a life expectancy of at least 12 weeks.
- Patients must have a Zubrod performance status of 0-2.
- Patients must sign an informed consent.
- Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 and absence of a regular red blood cell transfusion requirement.
Key exclusion criteria (4 listed)
- Patients with symptomatic brain metastases are excluded from this study.
- Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
- Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
- Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
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 |
|---|---|---|
| Gemcitabine, Docetaxel and BevacizumabAlso: Taxotere, Gemzar, AvastinDuring the treatment phase, pts. will receive the drug combination of gemcitabine, docetaxel, and bevacizumab every 2 weeks for a period of 4 weeks. This 4-week period is called a cycle of treatment. The treatment consists of receiving docetaxel IV over a 60-minute period and gemcitabine IV over a 30-minute period. Pts. will then receive bevacizumab IV over a 30-minute period. Pts. will receive this treatment once every 2 weeks. Pts. will receive at least 2 cycles of treatment unless you have progression of your disease or unmanageable side effects. As long as the size of pts.'s tumor stays the same or gets smaller, pts may continue receiving treatment | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Overall response rate (complete and partial responses).
Time frame: 4 years
Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). ORR is the sum of the percentages of patients achieving complete and partial responses
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 19 Jun 2015.
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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.
Claire Verschraegen, MD principal investigator
University of New Mexico
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemcitabine, Docetaxel and Bevacizumab in people with Sarcoma, run by New Mexico Cancer Research Alliance at 4 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?
The sponsor lists 6 inclusion and 4 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 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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.
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?
Overall response rate (complete and partial responses). (time frame: 4 years). 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 19 Jun 2015.