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

NCT00630409 | Completed Phase 2 Results DMC

• 1 other identifier: 04-033
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Renal cell carcinoma; Kidney Cancer; Gemcitabine; Doxil; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Number of participants that experienced response/total number of participants per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan. Response was defined as Complete Response (CR), the disappearance of all target lesions; Partial Response (PR), a 30% or greater decrease in the sum of the longest diameter of target lesions.

  Up to 18 weeks for individual; Up to 40 months for cohort

Secondary Outcomes (1)

• Time to Progression

  Up to 40 months

Study Arms (1)

Treatment

EXPERIMENTAL

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; Drug: Doxil

Interventions

Gemcitabine DRUG

800 mg IV day 1 and 8

Also known as: Gemzar

Treatment

Doxil DRUG

24 mg/m2 every 21 days IV

Also known as: doxorubicin, adriamycin

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Gemcitabine; liposomal doxorubicin; Doxorubicin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Leonard Appleman, MD, PhD
• Organization: University of Pittsburgh

applemanlj@upmc.edu

412-648-6538

Study Officials

• Leonard J Appleman, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: September 1, 2004
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 10, 2017
• Results First Posted: March 10, 2017

Record last verified: 2017-01

Locations

US (1)