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AzTrials

Metastatic Transitional Cell Cancer of the Renal Pelvis and UreterPhase 2NCT00041106

Gefitinib Plus Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Bladder Cancer

A Phase 2 study testing gemcitabine hydrochloride, cisplatin and gefitinib in people with Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter and Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, run by National Cancer Institute (NCI) at 1 site 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

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Combining chemotherapy with gefitinib may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
gemcitabine hydrochloride, cisplatin and gefitinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
May 2002to Jul 2007
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

Who may be able to join

  • Biopsy proven transitional cell carcinoma of the urothelial tract (bladder, ureter, renal pelvis or urethra); histologic documentation of metastatic/recurrent disease is not required; clinical, but not pathologic staging, is required
  • Metastatic (N2, N3 or M1) urothelial tract carcinoma; patients must not be candidates for potentially curative surgery or radiation therapy
  • Patients must have measurable disease as defined below:
  • Measurable disease: lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan; the bladder is not a site of measurable disease
  • Non-measurable disease: all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions; lesions that are considered non-measurable include the following:
  • Bone lesions
Show all 35Show fewer
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Inflammatory breast disease
  • Lymphangitis cutis/pulmonis
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions
  • Prior treatment:
  • No prior systemic chemotherapy except single-agent chemotherapy used as a radiosensitization agent; prior intravesical chemotherapy is permissible; prior adjuvant or neoadjuvant chemotherapy is not permissible
  • No prior systemic therapy for advanced urothelial carcinoma including investigational therapies such as, but not limited to, agents targeting the HER2/neu, signal transduction (including EGFR), angiogenic, immune, and cell cycle pathways
  • No prior treatment with ZD1839
  • > 4 weeks and fully recovered from major surgery, radiation, or intravesical chemotherapy
  • Tumor tissue from the primary tumor or from biopsy of a metastatic site must be available for EGFR expression determination; when tissue specimens from both primary and metastatic sites are available, both must be submitted for EGFR testing; expression of EGFR is not required
  • No cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers within 7 days prior to starting protocol therapy and while on protocol treatment; CYP3A4 inducers include phenytoin, carbamazepine, barbiturates, rifampin, St John's Wort, dexamethasone, modafinil, and rifapentine; single doses of dexamethasone used as an antiemetic are permitted
  • No evidence of brain metastases
  • Patient must have no evidence of:
  • > grade 1 pre-existing sensory or motor neuropathy
  • Active severe chronic gastrointestinal disorders including liver disease, diarrheal or emetic disorders, or malabsorptive conditions causing nausea or diarrhea
  • Active severe chronic desquamative cutaneous disorder
  • Active severe corneal disease or inflammatory ocular disorder
  • No "currently active" second malignancy other than non-melanoma skin cancers; patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse
  • No patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • No human immunodeficiency virus (HIV) disease
  • Common Toxicity Criteria (CTC) (Eastern Cooperative Oncology Group [ECOG]) performance status 0-2
  • Granulocytes >= 1,500/ul
  • Platelet count >= 100,000/ul
  • Bilirubin =< 1.25 x upper limits of normal
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.0 x upper limits of normal
  • Calculated creatinine clearance >= 50 ml/min

Who cannot join

  • Patients must not be pregnant or engaged in nursing; men and women of reproductive age must agree to practice effective contraception in order to participate in this study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cancer and Leukemia Group B

    Chicago, Illinois, 60606

Other trials in United States

About this study

Official title: Phase II Study Of Cisplatin, Gemcitabine, And ZD 1839 (IRESSA) (IND #61187; NSC 715055) For The Treatment Of Advanced Urothelial Tract Carcinoma

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Combining chemotherapy with gefitinib may kill more tumor cells. Phase II trial to study the effectiveness of combining chemotherapy with gefitinib in treating patients who have metastatic transitional cell cancer of the urothelium

Read the detailed description

PRIMARY OBJECTIVES:

  1. To describe the overall response proportion in patients with advanced carcinoma of the urothelial tract treated with cisplatin, gemcitabine (gemcitabine hydrochloride) and ZD1839 (gefitinib), given on a 21 day schedule, followed by maintenance ZD1839.

SECONDARY OBJECTIVES:

  1. To describe the time to progression, progression-free survival, and overall survival in patients with advanced carcinoma of the urothelial tract treated with cisplatin, gemcitabine and ZD1839, given on a 21 day schedule, followed by maintenance ZD1839.

II. To evaluate the effect of epidermal growth factor receptor (EGFR) expression level on overall response rate and progression-free survival in patients with advanced carcinoma of the urothelial tract treated with cisplatin, gemcitabine and ZD1839, given on a 21 day schedule, followed by maintenance ZD1839.

III. To assess the toxicity of the combination of cisplatin, gemcitabine and ZD1839 given on a 21 day schedule, followed by maintenance ZD1839 in patients with advanced carcinoma of the urothelial tract.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine intravenously (IV) over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1. Patients also receive gefitinib orally (PO) once daily (QD) beginning on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission, partial remission, or maintain stable disease continue gefitinib PO QD for 5 years or until disease progression or unacceptable toxicity occurs.

Patients are followed at least every 3 months for 1 year and then at least every 6 months until disease progression or relapse.

Being tested
gemcitabine hydrochloride, cisplatin, gefitinib, laboratory biomarker analysis

What participants receive

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

  • gemcitabine hydrochlorideDrug

    Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

    Given IV

  • cisplatinDrug

    Also called CACP, CDDP, CPDD, DDP

    Given IV

  • gefitinibDrug

    Also called Iressa, ZD 1839

    Given PO

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00041106
Study groupRoleWhat they receive
Treatment (gemcitabine, cisplatin, and gefitinib)ExperimentalPatients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1. Patients also receive gefitinib PO QD beginning on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission, partial remission, or maintain stable disease continue gefitinib PO QD for 5 years or until disease progression or unacceptable toxicity occurs.
Receives: Drug: gemcitabine hydrochloride; Drug: cisplatin; Drug: gefitinib; Other: laboratory biomarker analysis

What is being measured

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

  1. Objective response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as either a complete or partial response

    Exact 95% confidence intervals based on the binomial distribution will be computed.

    Measured: Up to 7 years

Secondary outcomes (3)

  1. Toxicity rates assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

    Exact 95% confidence intervals based on the binomial distribution will be computed.

    Measured: Up to 7 years

  2. Progression-free survival (PFS)

    The Kaplan-Meier product limit method will be used to estimate the PFS.

    Measured: From the date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 7 years

  3. Overall survival (OS)

    The Kaplan-Meier product limit method will be used to estimate the OS.

    Measured: From the date of initiation of treatment to date of death due to any cause, assessed up to 7 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 startMay 2002
  3. Primary 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00041106
Sponsor's protocol ID
NCI-2012-02818
Other IDs
CALGB-90102, CDR0000069443, U10CA031946
Status last verified
Jun 2013
First submitted
8 Jul 2002
Last updated
5 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride, cisplatin and gefitinib in people with Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter and Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, run by National Cancer Institute (NCI) at 1 site 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?

The sponsor lists 35 inclusion and 1 exclusion criteria. 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 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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?

Objective response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as either a complete or partial response (time frame: Up to 7 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 NCT00041106.

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 5 Jun 2013.

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