Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Eastern Cooperative Oncology Group

ClinicalTrials.gov Identifier:

NCT00053209

First received: January 27, 2003

Last updated: November 30, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 27, 2003

Last Updated Date

November 30, 2012

Start Date ^ICMJE

April 2004

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Response as measured by RECIST criteria [ Time Frame: Assessed every 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00053209 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to disease progression [ Time Frame: Assessed every 6 weeks ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium

Official Title ^ICMJE

Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer

Brief Summary

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining pemetrexed disodium with gemcitabine may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining pemetrexed disodium with gemcitabine in treating patients who have advanced cancer of the urothelium.

Detailed Description

OBJECTIVES:

Primary

Determine the response rate in patients with previously untreated advanced cancer of the urothelium treated with pemetrexed disodium and gemcitabine.
Determine the toxicity of this regimen in these patients.

Secondary

Determine the overall survival and time to progression in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Patients also receive cyanocobalamin intramuscularly once every 9 weeks and folic acid orally once daily beginning on day -6 and continuing until 3 weeks after the completion of study therapy. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 24-46 patients will be accrued for this study within 15 -18 months.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer

Intervention ^ICMJE

Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium

Study Arm (s)

Experimental: Pemetrexed Disodium and Gemcitabine

Pemetrexed disodium 500 mg/m2 followed by gemcitabine 1000 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on day 8 of a 21-day cycle for a maximum of 6 cycles

Interventions:

Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium

Publications *

Dreicer R, Li H, Cooney MM, Wilding G, Roth BJ. Phase 2 trial of pemetrexed disodium and gemcitabine in advanced urothelial cancer (E4802) : a trial of the Eastern Cooperative Oncology Group. Cancer. 2008 May 5; [Epub ahead of print]
Li S, Dreicer R, Roth B, et al.: Phase II trial of pemetrexed disodium and gemcitabine in advanced carcinoma of the urothelium (E4802): a trial of the Eastern Cooperative Oncology Group. [Abstract] J Clin Oncol 25 (Suppl 18): A-5079, 254s, 2007.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2009

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Histologically confirmed cancer of the urothelium (renal pelvis, ureter, bladder, or urethra)
- Any of the following types:
  - Transitional cell carcinoma (TCC)
  - Mixed histologies containing a component of TCC
  - Non-TCC of the urothelium (renal pelvis, ureter, bladder, or urethra)
Progressing regional or metastatic disease
Measurable disease
No clinical evidence of CNS metastases
No evidence of clinically significant (by physical exam or plain film) third-space fluid collections (pleural effusions or ascites)

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
Hemoglobin at least 9 g/dL

Hepatic

AST no greater than 3 times upper limit of normal (ULN)
Bilirubin no greater than 1.5 times ULN

Renal

Creatinine clearance at least 45 mL/min

Cardiovascular

No history of severe cardiovascular disease (i.e., American Heart Association class III or IV heart disease)
No uncontrolled congestive heart failure
No ventricular dysrhythmias

Other

Not pregnant or nursing
Fertile patients must use effective contraception
No active unresolved infection
No other prior malignancy unless curatively treated and disease free for an appropriate (disease-specific) period of time
Able and willing to receive folic acid and cyanocobalamin supplementation

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior systemic biologic response modifier therapy

Chemotherapy

No prior systemic chemotherapy for metastatic disease
More than 1 year since prior neoadjuvant or adjuvant chemotherapy

Endocrine therapy

Not specified

Radiotherapy

At least 4 weeks since prior radiotherapy and recovered
No prior pelvic radiotherapy
No concurrent radiotherapy

Surgery

At least 4 weeks since prior major surgery and recovered

Other

More than 7 days since prior parenteral antibiotics
No salicylates for 2 days before, during, and for 2 days after administration of pemetrexed disodium
No nonsteroidal anti-inflammatory drugs for at least 5 days before, during, and for 2 days after administration of pemetrexed disodium

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00053209

Other Study ID Numbers ^ICMJE

CDR0000269302, ECOG-E4802

Has Data Monitoring Committee

Responsible Party

Eastern Cooperative Oncology Group

Study Sponsor ^ICMJE

Eastern Cooperative Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Robert Dreicer, MD, FACP

The Cleveland Clinic

Information Provided By

Eastern Cooperative Oncology Group

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top