MedTrace Logo

S0121, Neoadjuvant Carboplatin, Paclitaxel, and Gemcitabine Followed by Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Carcinoma of the Urothelium

NCT00055835 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2013-01-31

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy before radiation therapy, and combining chemotherapy with radiation therapy, may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of neoadjuvant gemcitabine, paclitaxel, and carboplatin followed by cisplatin and radiation therapy in treating patients who have locally advanced or recurrent carcinoma (cancer) of the urothelium.

Conditions

Interventions

DRUG

carboplatin

\*AUC=5 (by modified Calvert formula), IV, over 15 minutes; given q 21 days for a maximum of 3 cycles (1 cycle = 21 days)

DRUG

cisplatin

75 mg/m2 (maximum dose 150 mg), IV, rapid infusion; given q 21 days for 2 cycles (1 cycle = 21 days)

DRUG

gemcitabine hydrochloride

800 mg/m2, IV, over 30 minutes; given on Days 1 \& 8, q 21 days, for a maximum of 3 cycles (1 cycle = 21 days)

DRUG

paclitaxel

200 mg/m2, IV, over 3 hours; given q 21 days for a maximum of 3 cycles (1 cycle = 21 days)

PROCEDURE

neoadjuvant therapy

Neoadjuvant chemotherapy (paclitaxel, carboplatin, and gemcitabine)

RADIATION

radiation therapy

Radiation treatments will be delivered once daily. Treatment will be given 5 days per week at a dose of 180 to 200 cGy per day. All fields will be treated everyday.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Ulka N. Vaishampayan, MD · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2006-06-30
Completion
2006-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00055835 on ClinicalTrials.gov