- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00134641
Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas
A Phase II Study Evaluating Efficacy of the Combination of Gemcitabine and Vinorelbine in Advanced Soft Tissue Sarcoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients will receive both gemcitabine and vinorelbine once a week for two weeks and then one week with no chemotherapy (1 cycle equals 21 days). Gemcitabine and vinorelbine will be administered on day 1 and day 8 of each cycle.
Blood tests will be performed on each day chemotherapy is administered. A CT scan will be done after every 2 cycles (approximately every 6 weeks) to determine the effects of the chemotherapy on the sarcoma.
A physical exam will be performed at the start of chemotherapy and at least every three weeks thereafter.
Patients will remain on this study as long as the disease does not progress or there are no unacceptable side effects.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, United States, 02115
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologic diagnosis of unresectable or metastatic soft tissue sarcoma
- Measurable disease outside of a prior irradiated area
- ECOG performance status 0,1, or 2.
- 0 or 1 prior regimens for advanced disease.
- Adequate end organ function, defined as bilirubin < 1.8; SGOT/SGPT < 2.5 x upper limit of normal (ULN); creatinine < 1.5 x ULN.
- Negative pregnancy test
- Life expectancy of greater than 3 months
Exclusion Criteria:
- Patient has received any investigational agents within 28 days of first day of study drug dosing
- Two or more prior regimens for advanced disease
- Prior gemcitabine or vinorelbine
- Another primary malignancy
- Grade III/IV cardia dysfunction
- Female patients who are pregnant or breast-feeding
- Severe and/or life-threatening medical disease
- Known diagnosis of HIV infection
- Prior chemotherapy within 4 weeks prior to study entry
- Major surgery within 2 weeks prior to study entry
- Known hypersensitivity to either gemcitabine or vinorelbine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
To determine the response of the combination of gemcitabine and vinorelbine in patients with metastatic soft tissue sarcoma
|
Secondary Outcome Measures
Outcome Measure |
---|
To determine the duration of response and the overall survival of patients with metastatic soft tissue sarcoma being treated with this combination
|
to evaluate the safety of this combination in this patient population
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Suzanne George, MD, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Sarcoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Vinorelbine
Other Study ID Numbers
- 02-282
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sarcoma, Soft Tissue
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma | Stage IIA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma
-
CytRxUnknownUnresectable Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Locally Advanced Soft Tissue SarcomaUnited States, Australia, Russian Federation, Hungary, India, Romania, Ukraine
-
University of WashingtonAadi Bioscience, Inc.Active, not recruitingAdvanced Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Locally Advanced Soft Tissue SarcomaUnited States
-
National Institutes of Health Clinical Center (CC)CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IVA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma | Stage IVB Adult Soft Tissue Sarcoma
-
National Cancer Institute (NCI)TerminatedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage I Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue SarcomaUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Alveolar Soft Part Sarcoma | Unresectable Alveolar Soft Part Sarcoma | Advanced Soft Tissue Sarcoma | Advanced Alveolar Soft Part SarcomaUnited States
-
Centre Leon BerardNovartis; National Cancer Institute, FranceRecruitingAdvanced Soft-tissue Sarcoma | Metastatic Soft-tissue SarcomaFrance
-
UNICANCERRecruitingAdvanced Soft-tissue Sarcoma | Metastatic Soft-tissue SarcomaFrance
-
University of Colorado, DenverAgenus Inc.RecruitingAdvanced Soft Tissue Sarcoma | Metastatic Soft Tissue SarcomaUnited States
-
Wake Forest University Health SciencesMerck Sharp & Dohme LLCCompletedSoft Tissue Sarcoma, Adult | Soft Tissue Sarcoma, ChildUnited States
Clinical Trials on gemcitabine
-
AstraZenecaRecruitingBiliary Tract CancerFrance, Spain, Italy, Korea, Republic of, Japan, Germany, United States, Singapore
-
Sierra Oncology LLC - a GSK companyCompletedAdvanced Solid TumorsSpain, United Kingdom
-
University of Erlangen-Nürnberg Medical SchoolCompleted
-
Shenzhen University General HospitalNot yet recruiting
-
3D Medicines (Sichuan) Co., Ltd.Not yet recruitingBiliary Tract Neoplasms
-
Kansai Hepatobiliary Oncology GroupCompleted
-
Fifth Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
-
3D Medicines (Sichuan) Co., Ltd.RecruitingBiliary Tract NeoplasmsChina
-
Yung NAQueen Mary Hospital, Hong Kong; Pamela Youde Nethersole Eastern HospitalRecruitingMuscle-Invasive Bladder Carcinoma | Muscle Invasive Bladder Urothelial CarcinomaHong Kong
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNot yet recruiting