Trial of Paclitaxel Plus Gemcitabine and Cisplatin in Bladder Cancer

NCT02560038 | Terminated Phase 2 Results DMC

• 2 other identifiers: GU-13-102HSC-MS-13-0864
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is for people with bladder cancer that has spread. The purpose of this research study is to see if the chemotherapy combination of gemcitabine and cisplatin plus paclitaxel is safe and effective treatment for bladder cancer. Paclitaxel, gemcitabine and cisplatin have all been approved by the United States Food and Drug Administration (FDA). Gemcitabine and cisplatin is a standard treatment for bladder cancer. There have been studies that show that paclitaxel and cisplatin have antitumor activity in bladder cancer. European researchers studied paclitaxel, gemcitabine and cisplatin (same drug combination in this trial) and found that the combination provided good disease control and was well tolerated. Investigators are studying the same drug combination, but at different dosages and schedule.

Conditions

Urinary Bladder Neoplasms

Keywords

Urothelial Cancer; Bladder Cancer; Metastatic

Outcome Measures

Primary Outcomes (1)

• Efficacy as Measured by the Objective Response Rate (ORR).

  Objective Response Rate (ORR) is defined as the proportion of patients achieving either a complete response or a partial response based on imaging at any time during the study. Complete response or partial response is based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months

Secondary Outcomes (2)

• Safety of Drug Regimen as Measured by Number of Adverse Events

  From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months

• Efficacy as Measured by Number Who Progressed

  From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months

Study Arms (1)

Combination chemotherapy

EXPERIMENTAL

Combination chemotherapy consisting of gemcitabine and cisplatin plus paclitaxel on a 21-day cycle.

Drug: Gemcitabine; Drug: Paclitaxel; Drug: Cisplatin

Interventions

Gemcitabine DRUG

1000 mg/m2 will be administered as an IV infusion over 10 mg/minute on Days 1 and 8 of each cycle (each cycle is 21 days).

Also known as: Gemzar

Combination chemotherapy

Paclitaxel DRUG

175 mg/m2 will be administered as an IVPB over 3 hours on Day 2 of each cycle (each cycle is 21 days).

Also known as: Taxol

Combination chemotherapy

Cisplatin DRUG

70 mg/m2 will be administered as an IVPB over 2 hours on Day 2 of each cycle (each cycle is 21 days).

Also known as: Platinol

Combination chemotherapy

Eligibility Criteria

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

You may qualify if:

• All patients must have histologic demonstration of metastatic or locally unresectable transitional cell carcinoma of the urothelium. Minor components (\<50% overall) of variants such as glandular or squamous differentiation, or evolution to more aggressive phenotypes, such as sarcomatoid, or small cell changes are acceptable. However, when these atypical histologies are dominant, other treatment approaches may be more appropriate, and such patients are not eligible.
• All patients must have measurable or evaluable disease. In general, liver and lung lesions should be at least 1 cm, and patients with node-only disease should have lesions of ≥ 1.5 cm in the largest dimension. Patients with disease confined to bone may be eligible if a measurable lytic defect is present. Patients with a 3-dimensional mass or pelvic sidewall fixation on bladder examination under anesthesia are considered to have measurable disease.
• All patients must have adequate physiologic reserves as evidenced by:
• Life expectancy of at least 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
• No clinical history of heart disease and a normal EKG or an ejection fraction measured by echocardiogram or MUGA scan of at least 45%.
• Transaminase less than twice the upper limit of normal. Bilirubin \<1.5 mg%.
• Serum creatinine ≤2.0 mg/dL. Patients presenting with obstructive uropathy may be eligible if they show excellent response to nephrostomy drainage.
• Absolute neutrophil count ≥1500; platelet count ≥100,000.
• Patients must not have had any previous systemic chemotherapy for bladder cancer, including neoadjuvant or adjuvant treatment given remotely. Gemcitabine/cisplatin is the standard of care for metastatic urothelial cancer. Patients who have received treatment would be either resistant or refractory to additional doses. In addition, they would have residual adverse effects from treatment and would be particularly susceptible to further neuropathic adverse events. Any prior intravesicular therapy is allowed.
• Women of childbearing potential must have a negative pregnancy test prior to starting therapy. Men and women of childbearing potential must be willing to consent using effective contraceptive while on treatment and for a reasonable period thereafter.
• Patients must not have an active, or likely to become active, second malignancy.
• Patients must be at least 6 weeks out from pelvic irradiation, and must not have had more than 10% of the bone marrow irradiated.

You may not qualify if:

• Patients with uncontrolled CNS metastasis are not eligible.
• Patients with a history of peripheral neuropathy greater than grade 1 are not eligible.
• Pregnant women are excluded.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

UTHealth Memorial Hermann Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Neoplasm Metastasis

Interventions

Gemcitabine; Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Limitations and Caveats

Early termination of study leading to small number of subjects analyzed

Results Point of Contact

• Title: Marka Lyons, Research Manager
• Organization: The University of Texas Health Science Center at Houston

Marka.Lyons@uth.tmc.edu

713-500-6919

Study Officials

• Robert J Amato, DO

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Professor, Department of Internal Medicine, Division of Oncology

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 25, 2015
• Study Start: October 1, 2015
• Primary Completion: September 14, 2017
• Study Completion: September 14, 2017
• Last Updated: November 28, 2018
• Results First Posted: October 10, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)