Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma (Kidney Cancer) - Full Text View

Sponsor:	Eastern Cooperative Oncology Group
Collaborators:	National Cancer Institute (NCI) Southwest Oncology Group Cancer and Leukemia Group B
Information provided by:	Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT00068393

Purpose

RATIONALE: Drugs used in chemotherapy, such as doxorubicin and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving doxorubicin together with gemcitabine works in treating patients with locally recurrent or metastatic unresectable renal cell carcinoma (kidney cancer).

Condition	Intervention	Phase
Kidney Cancer	Biological: filgrastim Biological: pegfilgrastim Drug: doxorubicin hydrochloride Drug: gemcitabine hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Trial of Doxorubicin and Gemcitabine in Metastatic Renal Cell Carcinoma With Sarcomatoid Features

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Gemcitabine Filgrastim Gemcitabine hydrochloride Lenograstim Granulocyte colony-stimulating factor Pegfilgrastim

U.S. FDA Resources

Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:

Response rate [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	December 2003
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the response rate of patients with locally recurrent or metastatic unresectable renal cell cancer with sarcomatoid features treated with doxorubicin and gemcitabine.
Determine the progression-free and overall survival of patients treated with this regimen.
Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin IV and gemcitabine IV over 30 minutes on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 2- or 3-10 or pegfilgrastim SC on day 2. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

After 6 courses, patients undergo a MUGA scan. Patients with a stable* left ventricular ejection fraction (LVEF) continue therapy as above. Patients who reach a total doxorubicin dose of 450 mg/m^2 and are found to have unstable cardiac function or who have an abnormal LVEF continue therapy with gemcitabine alone.

NOTE: *Stable cardiac function is defined as no decrease more than 15% of LVEF in absolute number and LVEF at least 35% in total function by MUGA.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 16-40 patients will be accrued for this study within 1.3-3.3 years.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed renal cell carcinoma
- Features must be of sarcomatoid histology
- Locally recurrent or metastatic disease not amenable to resection
Measurable disease
Original diagnostic material available for pathology review
No prior or concurrent brain metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

WBC greater than 3,000/mm^3 OR
Absolute neutrophil count greater than 1,500/mm^3
Platelet count greater than 100,000/mm^3

Hepatic

Bilirubin less than 1.5 mg/dL
AST less than 2 times upper limit of normal

Renal

Creatinine no greater than 2.0 mg/dL

Cardiovascular

No myocardial infarction within the past year
No congestive heart failure within the past year
No significant ischemic or valvular heart disease within the past year
LVEF at least lower limit of normal by MUGA

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Other prior malignancy allowed provided patient was curatively treated and has been disease free from that cancer
No active infection that would preclude study treatment
No other concurrent serious medical illness that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

At least 4 weeks since prior radiotherapy and recovered
- No previously irradiated lesions as the sole site of disease
No concurrent local radiotherapy for pain control or for life-threatening situations

Surgery

Prior nephrectomy allowed
Recovered from prior surgery

Other

No prior treatment for advanced disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068393

Show 92 Study Locations

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Southwest Oncology Group

Cancer and Leukemia Group B

Investigators

Study Chair:	Naomi S. Balzer-Haas, MD	Fox Chase Cancer Center
Study Chair:	Janice P. Dutcher, MD	Our Lady of Mercy Medical Center Comprehensive Cancer Center
Study Chair:	Elisabeth I. Heath, MD	Barbara Ann Karmanos Cancer Institute
Study Chair:	Matthew I. Milowsky, MD	Weill Medical College of Cornell University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Haas N, Manola J, Pins M, et al.: ECOG 8802: phase II trial of doxorubicin (Dox) and gemcitabine (Gem) in metastatic renal cell carcinoma (RCC) with sarcomatoid features. [Abstract] J Clin Oncol 27 (Suppl 15): A-5038, 2009.

Responsible Party:	Group Chair, Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT00068393 History of Changes
Other Study ID Numbers:	CDR0000322258, E8802, SWOG-E8802, CALGB-E8802, RPCI-NCG 85006
Study First Received:	September 10, 2003
Last Updated:	January 28, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eastern Cooperative Oncology Group:

stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Doxorubicin
Gemcitabine
Lenograstim

Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on February 12, 2012