Intravesical Gemcitabine and Docetaxel for BCG na ve Non-muscle Invasive Bladder Cancer

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Recruiting
participants needed

26
sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Updated on 19 February 2024

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cancer

hysterectomy

serum pregnancy test

bladder cancer

gemcitabine

docetaxel

bladder carcinoma

invasive bladder cancer

oophorectomy

luteinizing hormone

carcinoma

follicle stimulating hormone

hormone levels

bilateral oophorectomy

combination therapy

carcinoma in situ

bacillus calmette-guerin

transurethral resection

transitional cell carcinoma

intravesical bcg

transitional cell carcinoma of bladder

bcg vaccine

recurrent tumor

bilateral salpingectomy

hormone level

combined modality therapy

intravesical bcg therapy

Summary

A single-arm, two-stage, open-label, phase 2 study investigating the safety and efficacy of intravesical gemcitabine/docetaxel for bacillus Calmette-Guerin (BCG)-nave patients with non-muscle invasive bladder cancer (NMIBC). All participants will receive an induction course of gemcitabine/docetaxel instillations followed by maintenance instillations if initial efficacy is seen. In addition to providing initial efficacy data, this study will provide safety and long-term efficacy data on the combination regimen studied. A tolerable safety profile and demonstrated efficacy would support a potential, randomized phase 3 trial comparing the experimental combination therapy and standard of care intravesical BCG therapy.

Details

Condition	urinary tract neoplasm, bladder cancer, bladder cancer, bladder disorder, Urothelial Carcinoma Bladder
Age	18-100 years
Treatment	Gemcitabine, Docetaxel
Clinical Study Identifier	NCT04386746
Sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Histologically confirmed intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) on TURBT obtained within 90 days of registration defined according to modified EORTC risk criteria summarized as follows
	Low-risk tumors: Initial or recurrent tumor > 12 months after resection with all of the following
	Solitary tumor
	Low-grade
	< 3 cm
	No carcinoma in situ (CIS)
	Intermediate-risk tumors: All tumors not defined in the two adjacent categories (between the category of low- and high-risk)
	High-risk tumors: Any of the following
	T1 tumor
	High-grade
	CIS
	Multiple and recurrent and large (> 3 cm) Ta low-grade tumors (all conditions must be met for this point of Ta low-grade tumors)
	Note #1: Low-risk tumors as defined above are not eligible
	Note #2: Mixed histologies are permitted, provided a component of urothelial carcinoma is present
	Note #3: All patients with high-grade T1 (HGT1) should undergo a restaging TURBT
	Eastern Cooperative Oncology Group (ECOG) (WHO) performance status 0, 1, or 2
	Age 18 years old at time of consent
	Evidence of post-menopausal status or negative urinary or serum pregnancy test or female pre-menopausal patients is required. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply
	Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)
	Women 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)
	Subjects who give a written informed consent obtained according to local guidelines
Exclusion Criteria
	Subjects with muscle-invasive (i.e. T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on baseline radiographic imaging obtained within 90 days prior to study registration. The required radiographic imaging
	includes
	Abdomen/Pelvis - CT scan
	Chest - chest x-ray or CT scan
	Subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage
	Note: Subjects with history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post-treatment disease assessment (i.e. cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible
	Subjects with another active second malignancy with an estimated overall survival from the second malignancy of < 12 months. Subjects with another second active malignancy that are deemed to have an estimated overall survival of >12 months are eligible
	Subjects who have received the last administration of an anti-cancer therapy including chemotherapy, immunotherapy, and monoclonal antibodies 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
	Subjects who have had radiotherapy 4 weeks prior to starting study drug, or who have not recovered from radiotherapy toxicities
	Pregnant or breast-feeding women
	Subjects unwilling or unable to comply with the protocol
	Patients with prior systemic gemcitabine or docetaxel use for a non-bladder malignancy may enroll and receive treatment

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oophorectomy

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follicle stimulating hormone

hormone levels

bilateral oophorectomy

combination therapy

carcinoma in situ

bacillus calmette-guerin

transurethral resection

transitional cell carcinoma

intravesical bcg

transitional cell carcinoma of bladder

bcg vaccine

recurrent tumor

bilateral salpingectomy

hormone level

combined modality therapy

intravesical bcg therapy

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Intravesical Gemcitabine and Docetaxel for BCG na ve Non-muscle Invasive Bladder Cancer