Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer

NCT00028860 | Completed Phase 2

• 4 other identifiers: TULCC-RM-002CDR0000069142AMGEN-TULCC-RM-002BMS-TULCC-RM-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following surgery in treating patients who have urinary tract cancer.

Conditions

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

Keywords

stage III bladder cancer; stage IV bladder cancer; transitional cell carcinoma of the bladder; localized transitional cell cancer of the renal pelvis and ureter; regional transitional cell cancer of the renal pelvis and ureter

Interventions

filgrastim BIOLOGICAL

carboplatin DRUG

gemcitabine hydrochloride DRUG

ifosfamide DRUG

paclitaxel DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of transitional cell carcinoma of the urothelium including bladder, ureter, and renal pelvis * T3b-4, N0, M0 OR * Any T, N1-3, M0 * Cystectomy within the past 8 weeks PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * ECOG 0-1 Life expectancy: * At least 12 months Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST or ALT no greater than 2.5 times ULN Renal: * Creatinine no greater than ULN * Albumin no greater than ULN Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other prior malignancy except curatively treated carcinoma in situ of the cervix or non-melanoma skin cancer * No active serious infection, other serious underlying medical condition, dementia, or significantly altered mental status that would preclude study participation * No known hypersensitivity to Cremophor EL * No pre-existing clinically significant grade 2 or greater neuropathy * No AIDS (HIV positivity alone allowed) * No known hypersensitivity to E. coli-derived products PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for malignancy * No neoadjuvant chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for malignancy Surgery: * See Disease Characteristics Other: * No other concurrent investigational therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Tulane University Health Sciences Center: lead

Study Sites (1)

Tulane Cancer Center at Tulane University Hospital and Clinic

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Filgrastim; Carboplatin; Gemcitabine; Ifosfamide; Paclitaxel; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Oxazines; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Raja Mudad, MD, FACP

  Tulane University Health Sciences Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2002
• First Posted: January 27, 2003
• Study Start: October 1, 2001
• Study Completion: October 1, 2004
• Last Updated: July 10, 2013

Record last verified: 2004-08

Locations

US (1)