Trial of Combination ABI-007, Carboplatin, and Gemcitabine for First Line Treatment of Advanced Urothelial Cancer

NCT00995488 | Terminated Phase 2 Results DMC

• 2 other identifiers: 2009.025HUM00029138
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin and gemcitabine in the treatment of patients with advanced bladder cancer. Study participants will have been diagnosed with advanced bladder cancer. Cisplatin based chemotherapy in this setting has activity but is not curative. Furthermore, patients with this disease have comorbidities that limit the use of cisplatin based therapy. Combination paclitaxel, carboplatin and gemcitabine is active and well tolerated in this patient population. Paclitaxel is formulated with ethanol and a Cremophor EL (polyoxyethylated castor oil) which contribute to the side effects associated with paclitaxel. ABI-007 (brand name Abraxane™) is a form of paclitaxel that 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 based on superior anticancer effect, and is being evaluated in other cancers in research studies.

Conditions

Urothelial Cancer; Bladder Cancer

Keywords

Urothelial Cancer; ABI-007; Bladder Cancer; front-line

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Partial or Complete Response

  Clinical efficacy of ABI-007 based therapy will be determined by the overall response rate (Partial Response \[PR\] + Complete Response\[CR\]) to therapy. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Complete Response: Disappearance of all target lesions.

  2 years

Secondary Outcomes (1)

• Median Overall Survival

  2 years

Study Arms (1)

ABI-007

EXPERIMENTAL

ABI-007 combined with Carboplatin, and Gemcitabine

Drug: ABI-007 (Abraxane®)

Interventions

ABI-007 (Abraxane®) DRUG

ABI-007 is a novel albumin-bound paclitaxel combining a protein with a chemotherapeutic agent in the particle form.

Also known as: Abraxane, albumin-bound paclitaxel

ABI-007

Eligibility Criteria

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

You may qualify if:

• Male and female patients at least 18 years of age.
• Histologic or cytologic diagnosis of urothelial carcinoma (transitional cell carcinoma either pure or mixed histology) that is metastatic or locally recurrent or locally advanced and not eligible for higher priority trials.
• must have measurable disease.
• Patients must have recovered from any radiation therapy and must not have had more than 25% of the bone marrow irradiated.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Appendix 1.)
• Life expectancy of at least 12 weeks.
• Adequate organ and marrow function as defined below obtained within 14 days from registration:
• absolute neutrophil count \>1,500/µL
• platelets \>100,000/µL
• total bilirubin =1.5 mg/dL
• creatinine \<2.0 mg/dL
• AST and ALT \<2.5 X upper limits of normal
• Timing guideline for pre-study labs and measurements:
• All pre-study labs required for determination of eligibility are to be completed within 14 days prior to registration.
• X-rays and/or scans to assess all disease sites are to be completed within 1 month prior to registration (or the next business day if falls on a weekend or holiday).

You may not qualify if:

• Previous systemic chemotherapy for the current stage of disease.
• Prior treatment with ABI-007 or other taxane (prior treatment with taxane in neoadjuvant or adjuvant setting more than one year prior to registration is allowed).
• Pre-existing neuropathy that is \> grade 2 (i.e. interfering with patient function).
• History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan.
• Known HIV positive patients may not participate. This is to avoid additional complications that immune suppression and HIV infection may cause due to the intense nature of the chemotherapy in this trial.
• Concurrent treatment on another therapeutic clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.
• Pregnancy or breastfeeding. Female subjects must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female subjects with reproductive potential must have a negative pregnancy test (serum) prior to enrollment. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Alva A, Daignault S, Smith DC, Hussain M. Phase II trial of combination nab-paclitaxel, carboplatin and gemcitabine in first line therapy of advanced urothelial carcinoma. Invest New Drugs. 2014 Feb;32(1):188-94. doi: 10.1007/s10637-013-0054-5. Epub 2013 Dec 10.

  PMID: 24318901 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Albumin-Bound Paclitaxel

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)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Maha Hussain
• Organization: University of Michigan Comprehensive Cancer Center

mahahuss@umich.edu

734-647-8903

Study Officials

• Maha Hussain, MD

  University of Michigan Medical School/Internal Medicine Dept.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 15, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 11, 2015
• Results First Posted: September 19, 2014

Record last verified: 2015-08

Locations

US (1)