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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leonard Appleman, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00630409
First received: February 28, 2008
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Drug: Gemcitabine
Drug: Doxil
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: Treatment
Official Title: Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

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 ]

Enrollment: 19
Study Start Date: September 2004
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
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.
Drug: Gemcitabine
800 mg IV day 1 and 8
Other Name: Gemzar
Drug: Doxil
24 mg/m2 every 21 days IV

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630409

Locations
United States, Pennsylvania
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
  More Information

No publications provided

Responsible Party: Leonard Appleman, Assistant Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00630409     History of Changes
Other Study ID Numbers: 04-033
Study First Received: February 28, 2008
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Renal cell carcinoma
Kidney Cancer
Gemcitabine
Doxil
Chemotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014