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

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00055835

Purpose

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.

Condition	Intervention	Phase
Bladder Cancer Urethral Cancer	Drug: carboplatin Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Procedure: neoadjuvant therapy Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Evaluation of Carboplatin, Paclitaxel and Gemcitabine Followed by Concurrent Cisplatin and Radiation Therapy in Patients With Locally Advanced or Recurrent Urothelial Malignancy

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Cisplatin Paclitaxel Carboplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

November 2002

Detailed Description:

OBJECTIVES:

Determine the overall survival of patients with locally advanced or recurrent carcinoma of the urothelium treated with neoadjuvant carboplatin, paclitaxel, and gemcitabine followed by concurrent cisplatin and radiotherapy.
Determine the feasibility of administering this regimen to these patients.
Determine the progression-free survival of patients treated with this regimen.
Determine the qualitative and quantitative toxic effects of this regimen in these patients.
Determine the response rate (confirmed and unconfirmed) of patients treated with the neoadjuvant regimen and those treated with the whole regimen.
Determine the proportion of patients who qualify for concurrent cisplatin and radiotherapy after receiving the neoadjuvant regimen.
Determine the potential value of suppressor gene expression analysis (p53 and retinoblastoma gene) and HER2 expression as indicators of prognosis and/or response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive neoadjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 15 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity.

Within 4-8 weeks after the completion of neoadjuvant chemotherapy, patients receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for a maximum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent radiotherapy 5 days a week for 6 weeks.

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

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 4 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary or recurrent invasive carcinoma of the urothelium
- Transitional, squamous, or mixed cell subtypes allowed
- Primary disease site must be the urinary bladder or urethra
- Disease confined to the true pelvis (T2-T4, N0-N3, M0)
- Must meet at least 1 of the following criteria:
  - Nodal involvement at or below the level of the bifurcation of the iliac vessels
  - Medically or surgically inoperable
  - Patient refused cystectomy
Measurable or nonmeasurable disease
Evidence of tumor invasion of the muscularis by cystoscopy and biopsy and detailed bladder mapping within the past 56 days
No extrapelvic metastases
Eligible to receive radiotherapy
- Planned radiotherapy at a SWOG-approved facility

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-2

Life expectancy

Not specified

Hematopoietic

Granulocyte count at least 1,500/mm^3
Platelet count at least lower limit of normal

Hepatic

Bilirubin no greater than upper limit of normal (ULN)
SGOT or SGPT no greater than 2.5 times ULN

Renal

Creatinine clearance at least 60 mL/min OR
Creatinine no greater than ULN

Gastrointestinal

No chronic diarrhea
No malabsorption
No extensive diverticular disease of the colon
No inflammatory bowel disease
No other pre-existing gastrointestinal disorders

Other

Not pregnant or nursing
Fertile patients must use effective contraception
No active infections requiring antibiotics
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy for patients with a current diagnosis of advanced bladder cancer that is also the initial diagnosis
No prior systemic chemotherapy except adjuvant therapy for recurrent disease completed more than 6 months ago
No prior carboplatin
No prior paclitaxel
No prior gemcitabine

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
No prior pelvic radiotherapy

Surgery

See Disease Characteristics
Recovered from prior surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055835

Show 92 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Ulka N. Vaishampayan, MD

Barbara Ann Karmanos Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00055835 History of Changes
Other Study ID Numbers:	CDR0000271309, SWOG-S0121
Study First Received:	March 6, 2003
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent bladder cancer
stage III bladder cancer
squamous cell carcinoma of the bladder
stage II bladder cancer
recurrent urethral cancer

urethral cancer associated with invasive bladder cancer
anterior urethral cancer
posterior urethral cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Urethral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Urethral Diseases
Gemcitabine
Cisplatin
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses

Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 09, 2012