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Bladder CancerPhase 1NCT00003342

Combination Chemotherapy in Treating Patients With Advanced Bladder or Kidney Cancer

A Phase 1 study testing filgrastim, carboplatin and doxorubicin hydrochloride in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

Completed

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

Official record
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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: This phase I trial is studying the side effects of giving gemcitabine, doxorubicin, and paclitaxel together with carboplatin in… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
filgrastim, carboplatin and doxorubicin hydrochloride
How many people
30 participants
Where
2 sitesUnited States
Study dates
Dec 1997to Jul 2007
Phase
Phase 1
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 advanced transitional cell urothelial cancer
  • Clinical Stage IV: T any, N1-3, M0; T any, N any, M1; or cT4, Nx, M0 (bladder tumors)
  • Pathological Stage III or IV bladder cancer: T any, N1-3, M0; T3b, N0, M0; T4, N0, M0; and T4, Nx, M0
  • Pathological Stage III or IV urothelial cancer of the renal pelvis or ureter: T any, N1-3, M0; T3, N0, M0; T4, N0, M0; and surgery has been performed within 10 weeks of initiation of therapy
  • Impaired renal function (See Renal function tests)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100% OR
  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 150,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 times normal
  • Alkaline phosphatase less than 2 times normal
  • SGOT less than 2 times normal

Renal:

  • Creatinine greater than 1.5 mg/dL but no greater than 2.5 mg/dL OR
  • Creatinine clearance 30-59 mL/min

Cardiovascular:

  • Normal cardiac function by history, physical examination, and chest radiograph OR
  • If prior cardiac disease, left ventricular ejection fraction must be at least 50% by radionuclide ventriculogram or echocardiogram
  • No serious cardiac arrhythmias; including first, second, and third degree heart block
  • No New York Heart Association class III or IV heart disease

Other:

  • No uncontrolled infection
  • No other active cancer, except nonmelanomatous skin cancer and in situ carcinoma of the cervix curatively treated
  • Not pregnant
  • Effective barrier contraception required for all fertile patients during and for 6 months after therapy (encouraged to continue for 2 years or longer)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior systemic chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to the bladder
  • At least 4 weeks since any other prior radiotherapy

Surgery:

  • See Disease Characteristics

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

Other trials in United States

About this study

Official title: Phase I Trial of Dose-Dense Gemcitabine, Doxorubicin, Then Paclitaxel Plus Carboplatin In Patients With Transitional Cell Carcinoma of the Urothelium and Impaired Renal Function

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: This phase I trial is studying the side effects of giving gemcitabine, doxorubicin, and paclitaxel together with carboplatin in treating patients with advanced bladder or kidney cancer and impaired kidney function.

Read the detailed description

OBJECTIVES:

  • Determine the safety and toxicity of dose-dense carboplatin plus paclitaxel on a weekly schedule given in sequence after gemcitabine and doxorubicin in patients with renal impairment and metastatic or locally advanced transitional cell carcinoma of the urothelium.
  • Observe the outcome of this sequential systemic chemotherapy in these patients, or following surgical resection as adjuvant therapy in patients in whom poor renal function precludes the use of cisplatin-based chemotherapy.

OUTLINE: This is a dose escalation study of carboplatin.

Patients receive gemcitabine IV over 10 minutes and doxorubicin IV over 15 minutes for 5 doses on weeks 1, 3, 5, 7, and 9. Filgrastim (G-CSF) is given subcutaneously on days 3 through 10 of each 2-week course. On week 11, patients receive paclitaxel and carboplatin IV over 1 hour weekly for 12 weeks.

Each cohort of 3 patients is entered on sequentially increasing doses of carboplatin. If any patient experiences dose limiting toxicity (DLT), then 6 patients are entered at that dose level. If 3 patients experience DLT at any dose level, the maximum tolerated dose has been surpassed and a total of 6 patients are treated at the previous level.

Patients are evaluated at week 16 and at end of study.

PROJECTED ACCRUAL: There will be 18-30 patients accrued into this study over 9-15 months.

Keywords
stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, metastatic transitional cell cancer of the renal pelvis and ureter, localized transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

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

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 startDec 1997
  3. Primary completionJul 2007
  4. Study completionJul 2007

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 1
Primary purpose
Treatment
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003342
Sponsor's protocol ID
97-114
Other IDs
MSKCC-97114, NCI-G98-1438
Status last verified
Jul 2013
First submitted
1 Nov 1999
Last updated
3 Jul 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing filgrastim, carboplatin and doxorubicin hydrochloride in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

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 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003342.

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 3 Jul 2013.

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