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

NCT00041106 | Completed Phase 2

• 4 other identifiers: NCI-2012-02818CALGB-90102CDR0000069443U10CA031946
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. Phase II trial to study the effectiveness of combining chemotherapy with gefitinib in treating patients who have metastatic transitional cell cancer of the urothelium

Conditions

Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter; Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter

Outcome Measures

Primary Outcomes (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.

  Up to 7 years

Secondary Outcomes (3)

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

  Up to 7 years

• Progression-free survival (PFS)

  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

• Overall survival (OS)

  From the date of initiation of treatment to date of death due to any cause, assessed up to 7 years

Study Arms (1)

Treatment (gemcitabine, cisplatin, and gefitinib)

EXPERIMENTAL

Patients 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.

Drug: gemcitabine hydrochloride; Drug: cisplatin; Drug: gefitinib; Other: laboratory biomarker analysis

Interventions

gemcitabine hydrochloride DRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

Treatment (gemcitabine, cisplatin, and gefitinib)

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Treatment (gemcitabine, cisplatin, and gefitinib)

gefitinib DRUG

Given PO

Also known as: Iressa, ZD 1839

Treatment (gemcitabine, cisplatin, and gefitinib)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (gemcitabine, cisplatin, and gefitinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Interventions

Gemcitabine; Cisplatin; Gefitinib

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• George Philips

  Cancer and Leukemia Group B

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Primary Completion: July 1, 2007
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

US (1)