Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma

Completed · Phase 2

Conditions studied: Metastatic Renal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT00630409

Run by

University of Pittsburgh

People needed

5

Starts

2004-09-01

Expected to finish

2009-09-01

Last updated by the study team

2017-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 permitted.
• 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.
• Brain metastases:
• Patients requiring XRT or gamma-knife (or similar) therapy to the brain must wait at least 4 weeks after the completion of irradiation before starting therapy.
• Only patients with either stable or regressing brain metastases after irradiation, as determined by CT or MRI, are eligible for therapy.
• No systemic therapy within 28 days prior to enrollment except as below:
• No sorafenib, sunitinib, temsirolimus therapy within 14 days prior to enrollment.
• Toxicities from prior therapy must have resolved to ≤Grade I.
• Survival: anticipated survival of at least three months.
• Renal function: creatinine ≥ 2.0 mg/dL.
• Patients must have a MUGA scan or 2-D echocardiogram indicating an ejection fraction of ≥50% within 42 days prior to the first dose of study drug. The method used at baseline must be used for later monitoring.
• Prior to each new cycle of therapy: hepatic function: AST, ALT ≥ 3X the upper limit of normal, unless the liver is involved by tumor, in which case the transaminases must be ≥ 5X the upper limit of normal. Total bilirubin must be ≥ 1.5 mg/dL.
• Prior to each new cycle of therapy: bone marrow function: absolute neutrophil count (ANC) ≥ 1,500; platelet count ≥ 100,000; hemoglobin ≥ 10 g/dL.
• Performance status: ECOG 0 or 1.
• Age: ≥ 18 years.
• Signed informed consent must be obtained from participating individuals.
• Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during treatment and for three months after completing treatment. If a patient becomes pregnant while on study, the patient will be removed from the study and all drug treatment discontinued.

You may not qualify if…

• 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.

Where it is running

• Hillman Cancer Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.