Intravesicular Abraxane for Treatment-Refractory Bladder Cancer

NCT00583349 | Completed Phase 1 Results DMC

• 1 other identifier: AAAC1114
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I: To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose. To assemble tissue bank to assess molecular correlates for response to intravesical Abraxane therapy. The antibodies analyzed will include p53, p63, Stathmin, Tau and Ki67. Phase II: To evaluate the utility (potential for clinical efficacy) of Abraxane in the treatment of refractory non-muscle invasive and a subset of T2 TCC of the bladder as measured by response rate (defined as negative cytology and bladder biopsy). To further evaluate the safety and toxicity profile of intravesically administered Abraxane therapy.

Conditions

Bladder Cancer

Keywords

Bladder Cancer; Chemotherapy; Bladder Neoplasms

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)

  To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose (MTD). A DLT is defined by the National Cancer Institute Common Toxicity Criteria version 3.0

  6 weeks

• Number of Participants With Complete Response (CR) or No Response (NR) After Treatment

  To evaluate the utility (potential for clinical efficacy) of Abraxane in the treatment of refractory superficial transitional cell carcinomas (TCC) as measured by response rate (defined as negative cytology and bladder biopsy). Patients were considered to have a complete response if they had a negative biopsy and negative cytology. All patients with positive biopsies or cytology were classified as having no response.

  6 weeks

Secondary Outcomes (1)

• To Further Evaluate the Safety and Toxicity Profile of Intravesically Administered Abraxane Therapy.

  6 months

Study Arms (1)

Abraxane administration

EXPERIMENTAL

Phase I and Phase II: Patients will receive intravesical Abraxane by sterile urethral catheterization once weekly for six weeks. Phase II: If a complete response after six weekly installations is achieved, patients will receive additional monthly maintenance instillations until there is a positive cystoscopic biopsy or until a maximum of six additional instillations have been administered.

Drug: Abraxane

Interventions

Abraxane DRUG

Abraxane is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Intravesically administered, dose escalation, 6 weekly instillations

Also known as: Paclitaxel protein-bound

Abraxane administration

Eligibility Criteria

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

You may qualify if:

• Patients must have a diagnosis of transitional cell carcinoma (TCC) of the urinary bladder confirmed at the study institution. The patient must have demonstrated superficial recurrent bladder cancer refractory to standard intravesical therapy. This will include stage Ta, T1, Tis and exclude all patients with muscle invasion (T2). All patients with stage Ta will require documentation of high-grade histology. All grossly visible disease must be fully resected and pathologic stage will be confirmed at the institution where the patient is enrolled. Patients must exhibit disease recurrence after receiving some form of standard intravesical therapy, including Bacillus Calmette-Guerin (BCG), mitomycin, interferon or any combination thereof.
• Age \> 18 and must be able to read, understand and sign informed consent
• Performance Status: Eastern Cooperative Oncology Group (ECOG) 0,1 (See Appendix II )
• Peripheral neuropathy: must be \< grade 1
• Absolute neutrophil count \> 1,500/mm3
• Hemoglobin \>9.0 g/dl
• Platelet count \> 100,000/mm3
• Total Bilirubin must be within normal limits.
• Adequate renal function with serum creatinine ≤ 2.0 mg/dL
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN) for the institution, Alkaline phosphatase ≤ 2.5 x ULN for the institution, unless bone metastasis is present in the absence of liver metastasis
• Women of childbearing potential must have a negative pregnancy test.
• All patients of childbearing potential must be willing to consent to using effective contraception, i.e., intrauterine device (IUD), Birth control pills, Depo-Provera, and condoms while on treatment and for 3 months after their participation in the study ends.
• No intravesical therapy within 6 weeks of study entry
• No prior radiation to the pelvis

You may not qualify if:

• Prior systemic docetaxel or paclitaxel therapy.
• Any other malignancy diagnosed within 2 years of study entry (except basal or squamous cell skin cancers or non-invasive cancer of the cervix) is excluded.
• Concurrent treatment with any chemotherapeutic agent.
• Women who are pregnant or lactating.
• History of vesicoureteral reflux or an indwelling urinary stent.
• Participation in any other research protocol involving administration of an investigational agent within 3 months prior to study entry aside from the phase I segment of this study.
• History of neuropathy of any cause

Sponsors & Collaborators

• Columbia University: lead
• Celgene Corporation: collaborator

Study Sites (1)

Herbert Irving Pavillion 11th Floor

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Albumin-Bound Paclitaxel; Taxes

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; Economics; Health Care Economics and Organizations

Results Point of Contact

• Title: Dr. James McKiernan, John K. Lattimer Professor and Chair of Department of Urology
• Organization: Columiba University Medical Center

jmm23@cumc.columbia.edu

212-342-3976

Study Officials

• James M McKiernan, MD

  Columbia University Irving Medical Center, Urology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: December 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: February 1, 2014
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2025-02

Locations

US (1)