AzTrials
AzTrials

Kidney CancerPhase 2NCT00042965

Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer

A Phase 2 study testing capecitabine and gemcitabine hydrochloride in people with Kidney Cancer, run by Alliance for Clinical Trials in Oncology at 50 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy 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: Phase II trial to study the effectiveness of combining capecitabine with gemcitabine in treating patients who have metastatic kidney… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Cancer
What is being tested?
capecitabine and gemcitabine hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
50 sitesin 2 countries
Study dates
Oct 2002to Sep 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed renal cell carcinoma
  • Clinically confirmed metastatic disease (histologic documentation of metastatic disease not required)
  • Sarcomatoid renal cell carcinomas allowed
  • No pure sarcomas
  • No collecting duct (duct of Bellini) tumors, oncocytomas, or transitional cell tumors
  • Measurable disease
  • At least 20 mm by conventional techniques OR
  • At least 10 mm by spiral CT scan
  • Nonmeasurable lesions include the following:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Lymphangitis cutis/pulmonis
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions
  • Patients with known brain metastases are eligible if they have undergone prior surgical resection and/or cranial irradiation, they currently do not require steroids or anticonvulsants, and there is no progressive disease on CT scan or MRI at least 4 weeks after completion of radiotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal

Renal

  • Creatinine clearance at least 30 mL/min

Cardiac

  • No clinically significant cardiac disease
  • No congestive heart failure
  • No symptomatic coronary artery disease
  • No cardiac arrhythmias not well controlled with medication
  • No myocardial infarction within the past 12 months

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after study
  • No prior severe reaction to fluoropyrimidine therapy or known sensitivity to fluorouracil
  • No malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract that would preclude absorption of capecitabine

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 4 weeks since prior chemotherapy and recovered
  • No prior gemcitabine
  • No prior fluoropyrimidines (e.g., fluorouracil, floxuridine, capecitabine, or fluorouracil-uracil)
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • At least 4 weeks since prior megestrol
  • No concurrent hormones (e.g., megestrol) except steroids for adrenal failure, hormones for nondisease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • Prior radiotherapy to any lesion that may produce disability (e.g., unstable femur) allowed
  • No concurrent palliative radiotherapy

Surgery

  • See Disease Characteristics
  • At least 4 weeks since prior major surgery and recovered

Other

  • Any number of prior regimens allowed

Trial locations and contacts

50 sites in 2 countries.

50 sites in 2 countries

United States49 sites

  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • Green Mountain Oncology Group

    Bennington, Vermont, 05201

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center

    Burlington, Vermont, 05401-3498

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612-7323

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Veterans Affairs Medical Center - Columbia (Truman Memorial)

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • Veterans Affairs Medical Center - Durham

    Durham, North Carolina, 27705

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242-1009

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756-0002

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • North Shore University Hospital

    Manhasset, New York, 11030

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Weill Medical College of Cornell University

    New York, New York, 10021

  • Mount Sinai Medical Center, NY

    New York, New York, 10029

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Lifespan: The Miriam Hospital

    Providence, Rhode Island, 02906

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California, 94121

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94143-0128

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • Veterans Affairs Medical Center - Syracuse

    Syracuse, New York, 13210

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York, 13217

  • Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • Veterans Affairs Medical Center - White River Junction

    White River Junction, Vermont, 05009

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware, 19899

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center - University Campus

    Worcester, Massachusetts, 01655

Other trials in United States

Canada1 site

  • McGill University

    Montreal, Quebec, H2W 1S6

Other trials in Canada

About this study

Official title: A Phase II Study Of Capecitabine Plus Gemcitabine For Metastatic Renal Cell Carcinoma

RATIONALE: Drugs used in chemotherapy 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: Phase II trial to study the effectiveness of combining capecitabine with gemcitabine in treating patients who have metastatic kidney cancer.

Read the detailed description

OBJECTIVES:

  • Determine the objective response rate in patients with metastatic renal cell carcinoma treated with gemcitabine and capecitabine.
  • Determine the duration of overall and progression-free survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
Conditions
Kidney Cancer
Keywords
recurrent renal cell cancer, stage IV renal cell cancer
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00042965
Study groupRoleWhat they receive
Gemcitabine + capecitabineExperimentalPatients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR. Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
Receives: Drug: capecitabine; Drug: gemcitabine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    Measured: Up to 2 years

Secondary outcomes (2)

  1. Overall survival

    Measured: Up to 2 years

  2. Progression-free survival

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 2002
  3. Primary completionSep 2006
  4. Study completionSep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00042965
Sponsor's protocol ID
CALGB-90008
Other IDs
U10CA031946, CDR0000069488
Status last verified
Jul 2016
First submitted
5 Aug 2002
Last updated
14 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Stadler WM, Halabi S, Rini B, Ernstoff MS, Davila E, Picus J, Barrier R, Small EJ; Cancer and Leukemia Group B. A phase II study of gemcitabine and capecitabine in metastatic renal cancer: a report of Cancer and Leukemia Group B protocol 90008. Cancer. 2006 Sep 15;107(6):1273-9. doi: 10.1002/cncr.22117.

    PubMed 16909426

  • Stadler WM, Halabi S, Ernstoff MS, et al.: A phase II study of gemcitabine (G) and capecitabine (C) in patients with metastatic renal cell cancer (mRCC): a report of Cancer and Leukemia Group B #90008. [Abstract] J Clin Oncol 22 (Suppl 14): A-4515, 385s, 2004.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing capecitabine and gemcitabine hydrochloride in people with Kidney Cancer, run by Alliance for Clinical Trials in Oncology at 50 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00042965, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.

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