Intravesicular Abraxane for Treatment-Refractory Bladder Cancer

Completed · Phase 1/Phase 2

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT00583349

Run by

Columbia University

People needed

46

Starts

2008-12-01

Expected to finish

2014-02-01

Last updated by the study team

2025-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Hematologic-Inclusion within 2 weeks of start of treatment
• Absolute neutrophil count > 1,500/mm3
• Hemoglobin >9.0 g/dl
• Platelet count > 100,000/mm3
• Hepatic-Inclusion within 2 weeks of entry
• 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

Where it is running

• Herbert Irving Pavillion 11th Floor — New York, New York, United States

Full record on ClinicalTrials.gov

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