Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Locally Advanced Bladder Cancer
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase Two Trial of Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Patients With Locally Advanced Carcinoma of the Bladder |
- 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 ]
- 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 ]
| Enrollment: | 29 |
| Study Start Date: | December 2007 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
-
Drug: ABI-007, Carboplatin, Gemcitabine
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
- Pre-existing peripheral neuropathy > grade 2
- 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. (Treatment may begin at the conclusion of antibiotic therapy.)
- Pregnant or lactating women may not participate.
Contacts and Locations| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| Principal Investigator: | David C Smith, MD | University of Michigan |
More Information
No publications provided
| Responsible Party: | David C Smith, Professor of Internal Medicine, University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00585689 History of Changes |
| Other Study ID Numbers: | UMCC 2007.061, HUM 13486 |
| Study First Received: | December 26, 2007 |
| Last Updated: | May 10, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan Cancer Center:
|
Locally advanced urothelial carcinoma of the bladder |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Gemcitabine Carboplatin Paclitaxel Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 18, 2013