Phase 2 Trial of Nab-paclitaxel Plus S-1 vs Gemcitabine Plus Cisplatin as 1-line Chemotherapy of Patients With Local Advanced and/or Metastatic Transitional Cell Carcinoma of Urothelial Tract

NCT03051373 | Completed Phase 2

• 1 other identifier: BY-001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Gemcitabine plus cisplatin have been the most studied and used anticancer agents in patients with local advanced and/or metastatic transitional cell carcinoma of urothelial tract even if clinical benefits and survival remains limited. The purpose of this study is to test in a randomized trial enrolling patients for comparing the efficacy and safety of nab-paclitaxel plus S-1 with Gemcitabine plus cisplatin, in order to determine the most promising agents as the first line treatment of advanced and/or metastatic transitional cell carcinoma of urothelial tract.

Conditions

Carcinoma, Transitional Cell

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Measure the time of progression-free from start of treatment, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  up to 12 months

Secondary Outcomes (4)

• Overall response rate

  every 2 cycles (6 weeks) until treatment discontinuation, an expected average of 1 year.

• Disease control rate

  change from baseline in tumor assessment at 18 weeks (cycle 6).

• Overall survival

  every 8 weeks until disease progression or death on study, an expected average of 2 years. Patients with progressive disease will be followed every 3 months for the first year and every 6 months thereafter up to 5 years.

• The number of treatment-emergent adverse events (AEs) and serous adverse events (SAEs) as a measure of safety

  every 3 weeks until treatment discontinuation plus 30 days, an expected average of 1 year.

Study Arms (2)

nab-paclitaxel plus S-1

EXPERIMENTAL

Nanoparticle albumin-bound paclitaxel is given at 120mg/m2 intravenously over 30 minutes on day 1 and 8, in combination with S-1 which is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.

Drug: nanoparticle albumin-bound paclitaxel, S-1

Gemcitabine plus cisplatin

ACTIVE COMPARATOR

Gemcitabine is given at 1000mg/m2 combination with cisplatin 75mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.

Drug: Gemcitabine, cisplatin

Interventions

nanoparticle albumin-bound paclitaxel, S-1 DRUG

Nanoparticle albumin-bound paclitaxel is given at 120mg/m2 intravenously over 30 minutes on day 1 and 8, in combination with S-1 which is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.

Also known as: nab-paclitaxel abraxane ABI-007

nab-paclitaxel plus S-1

Gemcitabine, cisplatin DRUG

Gemcitabine is given at 1000mg/m2 combination with cisplatin 75mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.

Also known as: GEMXAR

Gemcitabine plus cisplatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed-consent form.
• Man or woman aged 18 years to 70 years.
• Histologically confirmed unresectable locally advanced or metastatic transitional cell carcinoma, occur in renal pelvis, ureter, urinary bladder or urethra: unresectable stage T3-4 tumor; lymph node metastasis; distance metastasis.
• Patients with mixed histology may be enrolled if the proportion of transitional cell carcinoma is the predominant component (\> 50% of the histopathology sample).
• Patient without prior anticancer therapy, except for radical excision. Prior adjuvant therapy is allowed, only if the documented relapse intervention \>12 months since completion of the last adjuvant therapy.
• At least one measurable tumor lesion (measurable disease, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1), and the measurable tumor received no local therapy (e.g. radiotherapy or cryotherapy).
• Eastern Cooperative Oncology Group (ECOG) 0-1, no progression within 2 weeks before enter into the trial, and with life expectation of no less than 12 weeks.
• Patients must have received no previous chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-fluorouracil or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
• Females of childbearing potential must have a negative serum pregnancy test and must not breast-feed before the first dose. Male also need contraception.

You may not qualify if:

• Patients who accepted any therapy blow:
• Patients who received prior systemic therapy, including chemotherapy, biotherapy, immunotherapy or experimental therapy, but except for adjuvant and neoadjuvant therapy.
• Undergo major surgery (except for revascularization) within 4 weeks prior to the first dose.
• Undergo radiotherapy to more than 30% of marrow, or large field irradiation within 4 weeks prior to the first dose.
• Patients who were taking (or can't stop within 1 weeks prior to the first dose) any certain drug or herbal supplements, which was known to be the inhibitor or inducer of cytochrome P450 (CYP) 3A4.
• Other anticancer therapy.
• The interval from the discontinuation of other investigational agent is less than 5 T1/2 of the drug.
• Patients were aware of receiving any similar therapy before.
• Concurrent or past history of another malignancy, need therapy within 2 years after the first dose.
• Any unresolved AE grade \>1 (CTCAE) from previous systemic therapy (e.g. adjuvant chemotherapy) before entry the trial, except for alopecia and grade 2 neuropathy induced by former chemotherapy.
• Patients with symptomatic central nervous system (CNS) metastasis.
• Patients with unstable or serious concurrent medical conditions are excluded. The researcher evaluates that the patient who is not suitable for participation in the study. Patients with active infection, but not limited in HBV, HCV, or HIV.
• Uncontrollable nausea, vomit, chronic gastrointestinal disorders leading to unable to swallow drugs, which may affect the fully absorption of S-1.
• Patients have active cardiac disease including any of the following:
• In resting state, average correction QTc \> 470 msec on mean value of 3 times screening ECGs, all data come from outpatient screening period.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100022, China

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Taxes; S 1 (combination); Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Doctor

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 13, 2017
• Study Start: April 1, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2020
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

CN (1)