Phase 2 Completed N=70 Treatment

Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer

Bladder Cancer

Source: ClinicalTrials.gov NCT00238420 ↗

Enrolled (actual)

Serious AEs

30.9%

Results posted

May 2016

Primary outcomePrimary: Acute Treatment-related Toxicity — 7; 14 participants

Summary

This phase I/II trial is studying the side effects of giving paclitaxel together with radiation therapy with or without trastuzumab and to see how well it works to kill any remaining tumor cells in patients who have undergone surgery for bladder cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel may also make tumor cells more sensitive to radiation therapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel together with radiation therapy and trastuzumab may kill more tumor cells. Giving these treatments after surgery may kill any remaining tumor cells.

Outcome Measures

Outcome	Result	p-value
PRIMARY Acute Treatment-related Toxicity	7; 14	—
SECONDARY Treatment Completion	13; 34	—
SECONDARY Complete Response to Treatment	61.5; 57.6	—
SECONDARY Progression-free Survival	1.1; 0.8	—
SECONDARY Overall Survival	2.8; 2.0	—

Eligibility Criteria

Inclusion Criteria

Histologically or cytologically confirmed primary transitional cell carcinoma (TCC) of the bladder
Histologic evidence of muscularis propria invasion
Meets 1 of the following stage criteria:
Stage T2-4a; NX, N0, or N1; and M0 disease
Clinical stage T1, grade 3/3 disease AND requires definitive local therapy
Tumor involvement of the prostatic urethra allowed provided the following criteria are met:
Tumor was visibly completely resected
No evidence of stromal invasion of the prostate
No evidence of distant metastases by chest x-ray (or chest CT scan) within 8 weeks prior to registration
No evidence of distant metastases by abdominal/pelvic CT scan (or MRI scan) within 8 weeks prior to registration
Has undergone transurethral bladder resection (as thorough as is judged safely possible) within the past 3-8 weeks, including bimanual examination with tumor mapping
Sufficient tumor tissue available for HER2/neu analysis
Not a candidate for radical cystectomy
Performance status - Zubrod 0-2
Absolute neutrophil count >= 1,800/mm^3
Platelet count >= 100,000/mm^3
Hemoglobin >= 8.0 g/dL (transfusion or other intervention allowed)
Bilirubin = 40% by multigated acquisition scan (MUGA) scan or echocardiogram
No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
No transmural myocardial infarction within the past 6 months
Not pregnant or nursing
No nursing for 6 months after completion of study treatment (for patients receiving trastuzumab [Herceptin®])
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after completion of study treatment
Able to tolerate systemic chemotherapy and pelvic radiotherapy
No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
No history of allergic reaction to study drugs
No history of inflammatory bowel disease
No acute bacterial or fungal infection requiring IV antibiotics
No AIDS
No other severe active comorbidity
No prior systemic chemotherapy with anthracyclines or taxanes
No prior systemic chemotherapy for TCC
No prior pelvic radiotherapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00238420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.