A Phase II single-arm trial to evaluate cisplatin and gemcitabine chemotherapy in combination with sunitinib for first-line treatment of patients with advancd transitional carcinoma of the urothelium. - SUCCINCT

Phase 1

• Conditions: Advanced transitional cell carcinoma of the urothelium.; MedDRA version: 9.1 Level: LLT Classification code 10005003 Term: Bladder cancer; MedDRA version: 9.1 Level: LLT Classification code 10038517 Term: Renal pelvis cancer NOS; MedDRA version: 9.1 Level: LLT Classification code 10046375 Term: Ureter cancer

• Registration Number: EUCTR2007-007591-42-GB
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-09
• Study Completion: 2013-07-18
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 63

Inclusion Criteria

1. Age greater than or equal to 16 years
2. Histologically confirmed transitional cell carcinoma (pure or mixed histology) of urothelium (upper or lower urinary tract)
3. Radiologically measurable, locally advanced and/or metastatic disease not amenable to curative treatment with surgery
or radiotherapy: (a) T4b (bladder) / T4 (renal pelvis / ureter) Nany Many, (b) Tany N2-3 Many, (c) Tany Nany M1
4. Estimated life expectancy greater than 3 months
5. WHO performance status 0-2
6. Fit to receive cisplatin-containing combination chemotherapy
7. No prior systemic therapy for locally advanced or metastatic disease - patients who have received prior neoadjuvant or adjuvant chemotherapy for urothelial cancer (up to 4 cycles), completed at least 6 months prior to first documented disease progression will remain eligible
8. No prior radiotherapy within 1 month prior to registration or involving more than 30% of total bone marrow volume
9. No investigational drug within 1 month prior to registration
10. Adequate renal function (GFR >60mL/min, uncorrected for surface area and measured by isotopic means)
11. Adequate bone marrow function (absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L; Plts greater than or equal to 100 x 109/L at baseline)
12. Adequate liver function (Bili less than or equal to 1.5x ULN; ALT and ALP less than or equal to 2.5 ULN at baseline)
13. Prothrombin time (PT) or International normalised ratio (INR) less than or equal to 1.5 x ULN
14. Written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with urothelial cancer in whom subsequent radical treatment is being considered with a view to possible cure
2. Previous malignancy other than non-melanoma skin cancer, cervical carcinoma in situ or incidental localised prostate cancer
3. Previously identified CNS metastases - routine baseline CT scanning of the head is not a requirement for trial entry and should only be performed if clinically indicated
4. Women who are pregnant or breast feeding. Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of trial therapy
5. Men and women not prepared to practice method(s) of birth control of established efficacy
6. Known infection with human immunodeficiency virus (HIV) or chronic hepatitis B or C
7. Uncontrolled hypertension
8. Symptomatic coronary artery disease, myocardial infarction within the last 6 months, congestive cardiac failure >NYHA class II, uncontrolled or symptomatic cardiac arrhythmia
9. Clinically significant bacterial or fungal infection
10. Concurrent anticoagulant therapy with warfarin or un-fractionated heparin - patients requiring anti-coagulation may be entered after successful conversion to low molecular weight heparin (LMWH)
11. Concomitant medications which have known adverse interactions with the trial treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified