SarcomaPhase 2NCT01593748
A Phase II Trial Comparing Gemcitabine and Pazopanib Versus Gemcitabine and Docetaxel for Patients With Advanced Soft Tissue Sarcoma
A Phase 2 study testing Gemcitabine and Pazopanib and Gemcitabine and Docetaxel in people with Sarcoma, run by Medical University of South Carolina at 8 sites in United States.
Trial summary
This study is for adult subjects with advanced tissue sarcoma. The study involves the drugs Pazopanib (Votrient), Gemcitabine (Gemzar), and Docetaxel (Taxotere). The purpose of this study is to test the effectiveness and safety of Gemcitabine and Pazopanib compared with Gemcitabine and Docetaxel in participants with… 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 and Pazopanib and Gemcitabine and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 8 sitesUnited States
- Study dates
- 27 Sep 2012to 24 Apr 2019
- 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
None listed.
Who cannot join
- Prior therapy with pazopanib, gemcitabine or docetaxel.
- Any concern for hypersensitivity to pazopanib, gemcitabine or docetaxel.
- Prior malignancy. Note: Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
- History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases.
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
- Active peptic ulcer disease
Show all 37Show fewer
- Known intraluminal metastatic lesion/s with risk of bleeding
- Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
- History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
- Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
- Malabsorption syndrome
- Major resection of the stomach or small bowel and experiencing the "dumping" syndrome.
- Presence of uncontrolled infection.
- Prior mediastinal radiation
- Corrected QT interval (QTc) > 480 msecs using Bazett's formula.
- History of any one or more of the following conditions within the past 6 months:
- Cardiac angioplasty or stenting
- Myocardial infarction
- Unstable angina
- Coronary artery bypass graft surgery
- Symptomatic peripheral vascular disease
- Pneumonitis
- Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) (Appendix D).
- Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥ 150 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg].
- Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP/DBP values from each BP assessment must be < 150/90 mmHg in order for a subject to be eligible for the study.
- -History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks prior to registration and are fully anti-coagulated are eligible.
- Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major).
- Evidence of active bleeding or bleeding diathesis.
- Known endobronchial lesions and/or lesions infiltrating major pulmonary Hemoptysis in excess of 2.5 mL (or one half teaspoon) within 8 weeks of first dose of study drug.
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
- Unable or unwilling to discontinue use of prohibited medications listed in Section 5.2.3 for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.
- Treatment with any of the following anti-cancer or non-oncologic investigational therapies:
- radiation therapy, surgery or tumor embolization within 14 days prior to registration.
- chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or 2.5 half-lives of a drug (whichever is longer) prior to registration.
- non-oncologic investigational products within 30 days or 5 halflives, whichever is longer.
- Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
University of Colorado Cancer Center
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21218
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa Hospitals & Clinics
Iowa City, Iowa
Washington University at St. Louis
St Louis, Missouri, 63130
The University of Arizona Cancer Center
Tucson, Arizona
About this study
Official title: A Randomized, Open-label, Phase II, Multi-center Trial of Gemcitabine (G) With Pazopanib (P) or Gemcitabine (G) With Docetaxel (T) in Previously Treated Subjects With Advanced Soft Tissue Sarcoma
This study is for adult subjects with advanced tissue sarcoma. The study involves the drugs Pazopanib (Votrient), Gemcitabine (Gemzar), and Docetaxel (Taxotere). The purpose of this study is to test the effectiveness and safety of Gemcitabine and Pazopanib compared with Gemcitabine and Docetaxel in participants with soft tissue sarcoma.
Read the detailed description
The purpose of this study is to test the effectiveness and safety of Gemcitabine and Pazopanib compared with Gemcitabine and Docetaxel in participants with soft tissue sarcoma. Screening tests will be done to ensure subjects are eligible to participate in this study. If the exams, tests and procedures show that subjects can be in the study, and they choose to take part, then they will be "randomized" into one of the two study groups: Group 1 or Group 2. Subjects in Group 1 will receive Gemcitabine 1000 mg/m2 intravenously (directly into a vein) on Day 1 and Day 8 and Pazopanib 800mg by mouth daily. Subjects in Group 2 will receive Gemcitabine 900 mg/m2 intravenously on Day 1 and Day 8 and Docetaxel 100 mg/m2 intravenously on Day 8. Both groups will be in 21 day cycles. Both groups will be asked to complete "quality of life" questionnaires, on their first visit, then at 6 weeks (2nd cycle), 18 weeks (6th cycle) and at the end of study treatment. Subjects will be followed for up to 2 years.
- Conditions
- Sarcoma
- Being tested
- Gemcitabine and Pazopanib, Gemcitabine and Docetaxel
- Keywords
- Sarcoma, 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.
Gemcitabine and PazopanibDrug
Gemcitabine 1000 mg/m2 by IV on day 1 and day 8 of a 21 day cycle. Pazopanib 800 mg by oral tablet daily for a 21 day cycle.
Gemcitabine and DocetaxelDrug
Gemcitabine 900 mg/m2 by IV on day 1 and day 8 of a 21 day cycle. Docetaxel 100 mg/m2 by IV on day 8 of a 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients in Group 1 will get Gemcitabine 1000 mg/m2 intravenously on Day 1 and Day 8 and Pazopanib 800mg by mouth daily on a 21 day cycle. Cycles will continue until disease progression or patient withdrawal. Receives: Drug: Gemcitabine and Pazopanib |
| Standard of Care | Active comparator | Patients in Group 2 will get Gemcitabine 900 mg/m2 intravenously on Day 1 and Day 8. Additionally on Day 8, patients will have Docetaxel 100 mg/m2 given intravenously. on a 21 day cycle. If disease progression occurs on this treatment, patients will have the option to receive treatment with Gemcitabine and Pazopanib (group 1). Receives: Drug: Gemcitabine and Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Number of Months of Progression-free Survival
To estimate the PFS of the combination of G+P or G+T in patients with metastatic and/or locally advanced or recurrent STS. Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Measured: minimum of 18 months
Rate of Participants With Grade 3 or Higher Toxicity
Toxicity is graded according to the CTCAE v 4.
Measured: 30 days post end of treatment
Secondary outcomes (3)
Hazard Ratio
Hazard ratio is defined as the rate of survival in the experimental group versus the standard of care group. A hazard ratio of greater than one or less than one means that survival was better in one of the groups.
Measured: minimum of 18 months
Average Score of Quality of Life
To estimate the quality of life of patient with metastatic an/or locally advanced recurrent STS using the Quality of Life Questionnaire (QLQ-C30). The QLQ-C30 is scored on a scale from 0-100 with "0" indicating "never" and "100" indicating "always" in regard the the participants' experience of fatigue, nausea/vomiting, pain, disponae, insomnia, appetite loss, constipation, diarrhea, financial concerns at 4 time points through the study.
Measured: Baseline, Cycle 2, Cycle 6 and End of Treatment
Response Rate
Response rate is defined as follows:
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
Measured: minimum of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study start27 Sep 2012
- Primary completion24 Apr 2019
- Study completion24 Apr 2019
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Daniel Y. Reuben, MD, Principal investigator, Medical University of South Carolina Hollings Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593748
- Sponsor's protocol ID
- 101644
- Other IDs
- PAZ115785, CPZP034BUS1T
- Status last verified
- Mar 2020
- First submitted
- 4 May 2012
- Last updated
- 6 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Xin G, Wang M, Jiao LL, Xu GB, Wang HY. Protein-to-creatinine ratio in spot urine samples as a predictor of quantitation of proteinuria. Clin Chim Acta. 2004 Dec;350(1-2):35-9. doi: 10.1016/j.cccn.2004.06.019.
PubMed 15530457National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
PubMed 11904577
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Phase II, Multi-center Trial of Gemcitabine (G) With Pazopanib (P) or Gemcitabine (G) With Docetaxel (T) in Previously Treated Subjects With Advanced Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT01593748
- Acronym / sponsor ID
- 101644
- Conditions
- Sarcoma
- Keywords
- Sarcoma, Soft Tissue Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 27 Sep 2012 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 8 May 2012 (estimated)
- Results
- Posted 6 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for adult subjects with advanced tissue sarcoma. The study involves the drugs Pazopanib (Votrient), Gemcitabine (Gemzar), and Docetaxel (Taxotere). The purpose of this study is to test the effectiveness and safety of Gemcitabine and Pazopanib compared with Gemcitabine and Docetaxel in participants with soft tissue sarcoma.
Detailed description
The purpose of this study is to test the effectiveness and safety of Gemcitabine and Pazopanib compared with Gemcitabine and Docetaxel in participants with soft tissue sarcoma. Screening tests will be done to ensure subjects are eligible to participate in this study. If the exams, tests and procedures show that subjects can be in the study, and they choose to take part, then they will be "randomized" into one of the two study groups: Group 1 or Group 2. Subjects in Group 1 will receive Gemcitabine 1000 mg/m2 intravenously (directly into a vein) on Day 1 and Day 8 and Pazopanib 800mg by mouth daily. Subjects in Group 2 will receive Gemcitabine 900 mg/m2 intravenously on Day 1 and Day 8 and Docetaxel 100 mg/m2 intravenously on Day 8. Both groups will be in 21 day cycles. Both groups will be asked to complete "quality of life" questionnaires, on their first visit, then at 6 weeks (2nd cycle), 18 weeks (6th cycle) and at the end of study treatment. Subjects will be followed for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Gemcitabine and PazopanibPatients in Group 1 will get Gemcitabine 1000 mg/m2 intravenously on Day 1 and Day 8 and Pazopanib 800mg by mouth daily on a 21 day cycle. Cycles will continue until disease progression or patient withdrawal. |
| Standard of Care | Active comparator | Drug: Gemcitabine and DocetaxelPatients in Group 2 will get Gemcitabine 900 mg/m2 intravenously on Day 1 and Day 8. Additionally on Day 8, patients will have Docetaxel 100 mg/m2 given intravenously. on a 21 day cycle. If disease progression occurs on this treatment, patients will have the option to receive treatment with Gemcitabine and Pazopanib (group 1). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (37 listed)
- Prior therapy with pazopanib, gemcitabine or docetaxel.
- Any concern for hypersensitivity to pazopanib, gemcitabine or docetaxel.
- Prior malignancy. Note: Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
- History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases.
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
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 and PazopanibGemcitabine 1000 mg/m2 by IV on day 1 and day 8 of a 21 day cycle. Pazopanib 800 mg by oral tablet daily for a 21 day cycle. | Drug | Experimental |
| Gemcitabine and DocetaxelGemcitabine 900 mg/m2 by IV on day 1 and day 8 of a 21 day cycle. Docetaxel 100 mg/m2 by IV on day 8 of a 21 day cycle. | Drug | Standard of Care |
Primary outcome
Average Number of Months of Progression-free Survival
Time frame: minimum of 18 months
To estimate the PFS of the combination of G+P or G+T in patients with metastatic and/or locally advanced or recurrent STS. Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Rate of Participants With Grade 3 or Higher Toxicity
Time frame: 30 days post end of treatment
Toxicity is graded according to the CTCAE v 4.
3 secondary outcomes
Hazard Ratio
Time frame: minimum of 18 months
Average Score of Quality of Life
Time frame: Baseline, Cycle 2, Cycle 6 and End of Treatment
Response Rate
Time frame: minimum of 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15530457Xin G, Wang M, Jiao LL, Xu GB, Wang HY. Protein-to-creatinine ratio in spot urine samples as a predictor of quantitation of proteinuria. Clin Chim Acta. 2004 Dec;350(1-2):35-9. doi: 10.1016/j.cccn.2004.06.019.
- Background: PubMed 11904577National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
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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.
Daniel Y. Reuben, MD principal investigator
Medical University of South Carolina Hollings Cancer Center
8 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 Gemcitabine and Pazopanib and Gemcitabine and Docetaxel in people with Sarcoma, run by Medical University of South Carolina at 8 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 0 inclusion and 37 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 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Yes. Results are posted in the registry (first posted 6 Apr 2020). 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?
Average Number of Months of Progression-free Survival (time frame: minimum of 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01593748, which also lists 2 linked publications.
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 6 Apr 2020.