Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Locally Advanced Bladder Cancer - Full Text View

Purpose

Study participants will have been diagnosed with bladder cancer that has invaded the muscle wall of the bladder. Surgery is used to remove cancer when it is in the muscle of the bladder. Unfortunately, approximately 50% of people may have their cancer return in another location. For this reason, researchers are focusing on new chemotherapy regimens to be given before surgery (to remove the bladder) that may decrease the likelihood of cancer spreading.

Paclitaxel, carboplatin and gemcitabine are chemotherapy drugs known to destroy bladder cancer cells.

ABI-007 (brand name Abraxane™) is a form of the chemotherapy drug called paclitaxel. Standard paclitaxel is formulated with ethanol and a substance called Cremophor EL (polyoxyethylated castor oil). However, these additives are felt to contribute to the side effects (possibly severe) associated with paclitaxel. ABI-007 does not contain these additives and may deliver more drug to tumor cells. ABI-007 is approved by the United States Food and Drug Administration (FDA) in the treatment of metastatic (advanced) breast cancer, and is being evaluated in other cancers in research studies.

This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin and gemcitabine in the treatment of bladder cancer prior to surgery to remove the bladder.

Condition	Intervention	Phase
Bladder Cancer	Drug: ABI-007, Carboplatin, Gemcitabine	Phase II

Genetics Home Reference related topics:

bladder cancer

MedlinePlus related topics:

Bladder Cancer Cancer

Drug Information available for:

Carboplatin Gemcitabine hydrochloride Gemcitabine Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase Two Trial of Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Patients With Locally Advanced Carcinoma of the Bladder

Further study details as provided by University of Michigan:

Primary Outcome Measures:

Estimate the rate of pathologic complete response following three cycles of neoadjuvant ABI-007, carboplatin and gemcitabine in patients with invasive urothelial carcinoma. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess the ability to predict response to chemotherapy using gene expression profiles and SPARC in tumor specimens [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	54
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Intervention Details:

ABI-007 will be administered at a dose of 100 mg/m2 over a 30 min IV infusion on days 1 & 8 of each 21 day cycle. Carboplatin will be administered at a dose of TARGET AUC=5 over a 15 min IV infusion of day 1 of each 21 day cycle. Gemcitabine will be administered at a dose of 800 mg/m2 over a 30 min IV infusion on days 1 and 8 of each 21 day cycle.

Eligibility

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

Criteria

Inclusion Criteria:

Histologically proven locally advanced (T2-4,N0,M0 or Tany,N1-3,M0) urothelial carcinoma of the bladder and be candidates for cystectomy following chemotherapy. Tumor specimens must be available for assay of molecular markers (correlative research).
Performance status of 0, 1 or 2 by Eastern Cooperative Oncology Group (ECOG) criteria.
Serum creatinine <2.0 mg/dl and/or creatinine clearance >40 ml/min.
Granulocyte count > 1,500/mm3, platelet > 100,000/mm3, and hemoglobin > 9.0 g/dl.
Adequate liver functions: AST and ALT < 2.5 X upper limit of normal, alkaline phosphatase < 2.5 X upper limit of normal, and bilirubin < 1.5 mg/dl.
Recovered from any effects of surgery.
Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Women with reproductive potential must have a negative pregnancy test.

Exclusion Criteria:

Prior systemic or intra-arterial chemotherapy and rior radiotherapy. (intravesical chemotherapy allowed.)
Pre-existing peripheral neuropathy > grade 2
Prior malignancy [except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for 2 years]
Unresolved bacterial infection (requiring active treatment with antibiotics) May be treated at the conclusion of antibiotic therapy.
Pregnant or lactating women may not participate.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585689

Contacts


Contact: Cancer AnswerLine	1-800-865-1125

Locations


United States, Michigan
	University of Michigan	Recruiting
	Ann Arbor, Michigan, United States, 48109
	Principal Investigator: David C Smith, MD
	Sub-Investigator: Maha Hussain, MD
	Sub-Investigator: Kathleen Cooney, MD
	Sub-Investigator: Deborah Bradley, MD

Sponsors and Collaborators

University of Michigan

Abraxis BioScience Inc.

Investigators


Principal Investigator:	David C Smith, MD	University of Michigan

More Information

Responsible Party:	University of Michigan ( David C, Smith, M.D. )
Study ID Numbers:	UMCC 2007.061
First Received:	December 26, 2007
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00585689
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:

Locally advanced urothelial carcinoma of the bladder

Study placed in the following topic categories:

Urinary Bladder Diseases

Urinary Bladder Neoplasms

Urogenital Neoplasms

Carboplatin

Carcinoma, Transitional Cell

Urologic Neoplasms

Transitional cell carcinoma

Carcinoma

Urologic Diseases

Paclitaxel

Gemcitabine

Urinary tract neoplasm

Bladder neoplasm

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Antimetabolites, Antineoplastic

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Mitosis Modulators

Physiological Effects of Drugs

Enzyme Inhibitors

Antimitotic Agents

Antiviral Agents

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Radiation-Sensitizing Agents

Therapeutic Uses

Tubulin Modulators

Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 28, 2008

Sponsors and Collaborators:	University of Michigan Abraxis BioScience Inc.
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00585689