Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma
This study has been completed.
Information provided by (Responsible Party):
Leonard Appleman, University of Pittsburgh
First received: February 28, 2008
Last updated: January 17, 2013
Last verified: January 2013
The purpose of this study is to test the hypothesis that the combination of gemcitabine and doxil will have clinical activity in patients with metastatic renal cell carcinoma.
Metastatic Renal Cell Carcinoma
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma
Primary Outcome Measures:
- Response rate [ Time Frame: 9 and 18 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to progression [ Time Frame: 9 and 18 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2009 (Final data collection date for primary outcome measure)
Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.
800 mg IV day 1 and 8
Other Name: Gemzar
24 mg/m2 every 21 days IV
Patients with metastatic renal cell carcinoma who have received prior therapy with sorafenib, sunitinib or temisolimus and have progressive disease may participate in this study if all eligibility criteria are met. Doxil will be administered on day 1 and gemcitabine on day 1 and 8 of a 21 day cycle. Tumor responses will be evaluated by RECIST. Up to six cycles of study treatment may be administered. Cardiac ejection fraction will be monitored.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients with renal cell carcinoma who have had disease progression through sorafenib, sunitinib, or temsirolimus (within 6 months of treatment).
- Diagnosis of RCC has been confirmed by pathological or cytological examination of tissue obtained from the primary tumor or a metastatic site.
- Clear cell and non-clear cell histological variants are permitted.
- With the exception of prior gemcitabine or any anthracycline (e.g., doxorubicin, epirubicin, DOXIL), any number of prior therapies with are permited.
- Prior nephrectomy is permitted but not required for eligibility.
- Patients who have received palliative radiation therapy (XRT) to any area other than the brain (see below) may begin therapy immediately after completion of XRT as long as the irradiated lesion(s) is/are not used for clinical response assessment.
- Patients who have received prior therapy with gemcitabine or an anthracycline drug (e.g., doxorubicin, epirubicin, DOXIL).
- Patients with untreated central nervous system metastases.
- Patients with active bacterial or fungal infections.
- Patients with psychiatric disorders that would interfere with consent, compliance with protocol requirements, or follow-up.
- Patients with a history of prior malignancy other than RCC, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years.
- Patients with any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for the entry into the study.
- Pregnant or lactating women.
- History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the component of DOXIL,
- History of cardiac disease with New York Heart Association Class II or greater cardiac function or clinical evidence of congestive heart failure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00630409
|Hillman Cancer Center
|Pittsburgh, Pennsylvania, United States, 15232 |
University of Pittsburgh
No publications provided
||Leonard Appleman, Assistant Professor of Medicine, University of Pittsburgh
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 28, 2008
||January 17, 2013
||United States: Institutional Review Board
Keywords provided by University of Pittsburgh:
Renal cell carcinoma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs