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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter

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Trial Information

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


PRIMARY OBJECTIVES:

I. 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:

I. 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.


Inclusion Criteria:



- 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

- 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

Up to 7 years

Safety Issue:

No

Principal Investigator

George Philips

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02818

NCT ID:

NCT00041106

Start Date:

May 2002

Completion Date:

Related Keywords:

  • Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms

Name

Location

Cancer and Leukemia Group BChicago, Illinois  60606