Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma (GVPS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Fudan University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Fudan University
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01192633
First received: March 25, 2010
Last updated: August 31, 2010
Last verified: August 2010
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Purpose
The primary objective of this study is to evaluate PFS of gemcitabine,vincristine and cisplatin as second line therapy in patients with sarcoma. 40 patients will be treated into this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma Chemotherapy |
Drug: GVP |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Phase Ⅱ Study of Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma |
Resource links provided by NLM:
Further study details as provided by Fudan University:
Primary Outcome Measures:
- Progression-free Survival(Progression-free survival was evaluated for the period from the date of first treatment with this regimen to the date when disease progression was first observed or death occurred.) [ Time Frame: every 6 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Response Rate [ Time Frame: every 6 weeks ] [ Designated as safety issue: Yes ]
- Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Side Effects [ Time Frame: every 3 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: GVP
Drug: gemcitabine, vincristine,cisplatin
cisplatin 25mg/m2，ivgtt，D1, 2, 3 gemcitabine 1000mg/m2，ivgtt，30'，D1, 8 vincristine 1.4mg/m2(less than 2 mg), iv, D1 repeat every 3 weeks
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Give written informed consent prior to study, with understanding that the patient has the right to withdraw from the study at any time without prejudice
- Be female of male and ≥18 and ≤75 years of age
- Be ambulatory and have ECOG performance status of ≤1
- Have histological confirmed sarcoma
- Locally advanced or metastatic sarcoma who receive first-line chemotherapy.
- Have at least one target lesion according to the RECIST criteria.
Exclusion Criteria:
- Pregnant or lactating women
- patient has received chemotherapy drugs including gemcitabine,vincristine and cisplatin
- Chemotherapy within four weeks preceding treatment start
- ECOG ≥ 2
- Radiotherapy to the axial skeleton within the 4 weeks preceding study treatment start or insufficient recovery from the effects of prior radiotherapy
- Participation in any investigational drug study within 4 weeks preceding treatment start
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix .Abnormal laboratory values: hemoglobin < 8. 0g/dl, neutrophil< 1.5×109/L, platelet< 100×109/L.
- serum creatine > upper limit of normal (ULN)
- serum bilirubin > ULN
- alanine aminotransferase(ALT) and aspartate aminotransferase(AST)>5×ULN
- alkaline phosphatase(AKP)>5×ULN
- Serious uncontrolled intercurrence infection
- Life expectancy of less than 3 months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192633
Contacts
| Contact: Zhiguo Luo, PhD | 862164175590 ext 8908 | luozhiguo88@yahoo.com.cn |
Locations
| China, Shanghai | |
| Fudan University Cancer Hospital | Recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: Zhiguo Luo, PhD | |
| Sub-Investigator: Zhiyu Chen, PhD | |
Sponsors and Collaborators
Fudan University
Investigators
| Principal Investigator: | Xiaonan Hong, MD | Fudan University |
More Information
Publications:
| Responsible Party: | Base for drug clinical trials, Fudan University cancer hospital, Fudan University cancer hospital |
| ClinicalTrials.gov Identifier: | NCT01192633 History of Changes |
| Other Study ID Numbers: | GVP-SAR |
| Study First Received: | March 25, 2010 |
| Last Updated: | August 31, 2010 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Fudan University:
|
Sarcoma gemcitabine vincristine cisplatin chemotherapy |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Gemcitabine Cisplatin Vincristine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 18, 2013