Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Phase II Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer
Brief Summary: Gemcitabine has been shown to be highly effective and well tolerated in the first and second line therapy, as a single agent or in combination therapy for treatment of metastatic transitional cell carcinoma. On the basis of Gemcitabine clinical activity and good tolerability this drug has been recently tested in intravesical therapy. we consider Gemcitabine as a good therapy candidate for patient with intermediate risk superficial bladder cancer. Based on the phase I/II clinical trials w are going to explore the efficacy and tolerability of Gemcitabine in this setting, and compare it to Mitomycin C which is widely used in this group of patients.


Options:
A: Inclusion Criteria:

* Histologically verified superficial transitional cell carcinoma of the bladder.
* patients with primary or recurrent intermediate risk superficial bladder cancer after TUR. Patients with primary tumor with stage TaG1 with multiple lesions (\>3) or lesions bigger than 3 cm or patients with TaG2-3 or T1G1-2.
* Patients must not be pre-treated with any intravesical immunotherapy (BCG) or chemotherapy.
* Male or female, age greater than 18.

Exclusion Criteria:

* Time between TUR and start of intravesical chemotherapy will be longer than 4 weeks.
* Patients who have received previous (BCG) or chemotherapy.
* Patients with evidence of invasive, locally advanced or metastatic bladder cancer (greater than or equal to T2 disease; stage greater than or equal to B1) or patients with upper urinary tract disease.
B: Inclusion Criteria:

* Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the bladder. Variant pathology are allowed
* Tumor with specified fibroblast growth factor receptor (FGFR) mutations or fusions
* Bacillus Calmette- Guerin (BCG)-unresponsive after adequate BCG therapy or BCG experienced participants
* Refuses or is not eligible for cystectomy (Cohort 1 and Cohort 2 only)
* Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-1
* Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
* A woman of childbearing potential must have a negative pregnancy test (beta-human chorionic gonadotropin \[beta-hCG\]) (urine or serum) within 7 days before randomization (Cohort 1) or the first dose of study drug (Cohort 2 and Cohort 3)
* Adequate bone marrow, liver, and renal function as specified in the protocol

Exclusion Criteria:

* Histologically confirmed, muscle-invasive (T2 or higher stage) urothelial carcinoma of the bladder
* Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder
* Prior treatment with an FGFR inhibitor
* Active malignancies other than the disease being treated under study. The only allowed exceptions are: (a) skin cancer treated within the last 24 months that is considered completely cured (b) adequately treated lobular carcinoma in situ (LCIS) and ductal CIS (c) history of localized breast cancer and receiving antihormonal agents, or history of localized prostate cancer (N0M0) and receiving androgen deprivation therapy
* Current central serous retinopathy or retinal pigment epithelial detachment of any grade
C: 1. Patients with bladder cancer in follow-up for tumor recurrence (Note: Patients must be included only at the first surveillance cystoscopy after a histologically confirmed tumor. The histologically confirmed tumor could either be from a TURB or from a surveillance cystoscopy where a biopsy was taken and a tumor was confirmed by histology)
2. History of one or more of the following:

   * Multiple tumors
   * Recurrent tumors
   * High grade tumor(s)

Exclusion Criteria:

1. Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in significant amounts of blood in the urine, which may visually limit cystoscopy. Where the haematuria is light, the patient should not be excluded, if in the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will alleviate the haematuria limitations to cystoscopy)
2. Patients who cannot undergo in-office or operating room cystoscopy (Note: Training patients are eligible even if they cannot undergo operating room cystoscopy)
3. Patients who have received Bacillus Calmette-Guérin (BCG) immunotherapy or intravesical chemotherapy within the past 6 weeks prior to the procedure
4. Porphyria
5. Known allergy to hexaminolevulinate hydrochloride or a similar compound
6. Pregnancy or breast-feeding (all women of child-bearing potential must document a negative urine pregnancy test before study inclusion and use adequate contraception during the study
7. Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days
8. Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
9. Patients that the investigator believes are unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of participating in the clinical study, uncooperative attitude or unlikelihood of completing the study
D: Inclusion Criteria:

* Clinical evidence of superficial transitional cell carcinoma of the bladder
* Males or females at least 18 years of age
* Karnofsky Performance Status greater than or equal to 70%
* Patient compliance and geographic proximity that allow adequate follow-up
* Female patients with reproductive potential must use a reliable contraceptive method if appropriate (for example, intrauterine device \[IUD\], birth control pills, or barrier device) during the study. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days of study enrollment.
* Signed informed consent.

Exclusion Criteria:

* Clinical evidence of muscle-invasive or locally advanced bladder cancer
* Clinical evidence of upper urinary tract tumor
* Distant metastases
* Other malignancies within the last 2 years, except non-melanotic skin tumors, carcinoma in situ of the cervix or organ-confined prostate cancer after curative therapy
* Severe concomitant psychiatric disease
* Febrile, active infection
* Other serious concomitant disorders that would compromise the safety of the patient or his/her ability to complete the study according to the protocol, at the discretion of the investigator (for example, unstable angina pectoris, uncontrolled diabetes mellitus)

Answer: A