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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gemcitabine; Pemetrexed

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