Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium
This study has been completed.
Sponsor:
Eastern Cooperative Oncology Group
Collaborator:
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Drug: gemcitabine hydrochloride Drug: pemetrexed disodium |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
bladder cancer
Drug Information available for:
Gemcitabine
Gemcitabine hydrochloride
Pemetrexed
Pemetrexed disodium
U.S. FDA Resources
Further study details as provided by Eastern Cooperative Oncology Group:
Primary Outcome Measures:
- Response as measured by RECIST criteria [ Time Frame: Assessed every 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 46 |
| Study Start Date: | April 2004 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Drug: gemcitabine hydrochloride Drug: pemetrexed disodium |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053209
Show 121 Study Locations
Show 121 Study LocationsSponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
| Study Chair: | Robert Dreicer, MD, FACP | The Cleveland Clinic |
More Information
Additional Information:
Publications:
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.
| Responsible Party: | Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00053209 History of Changes |
| Other Study ID Numbers: | CDR0000269302, ECOG-E4802 |
| Study First Received: | January 27, 2003 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Eastern Cooperative Oncology Group:
|
metastatic transitional cell cancer of the renal pelvis and ureter recurrent transitional cell cancer of the renal pelvis and ureter regional transitional cell cancer of the renal pelvis and ureter transitional cell carcinoma of the bladder recurrent bladder cancer stage III bladder cancer |
stage IV bladder cancer anterior urethral cancer posterior urethral cancer recurrent urethral cancer urethral cancer associated with invasive bladder cancer |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urethral Neoplasms Carcinoma, Transitional Cell Kidney Neoplasms Ureteral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Urethral Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Kidney Diseases Ureteral Diseases Gemcitabine Pemetrexed Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 17, 2013