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BRIEF TITLE: Phase II Trial of Paclitaxel Plus Gemcitabine and Cisplatin in Urothelial Cancer

Phase II Trial of Paclitaxel Plus Gemcitabine and Cisplatin in Urothelial Cancer


  • Org Study ID: GU-13-102
  • Secondary ID: HSC-MS-13-0864
  • NCT ID: NCT02560038
  • NCT Alias:
  • Sponsor: The University of Texas Health Science Center, Houston - Other
  • Source: The University of Texas Health Science Center, Houston

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.

Detailed Description


The rationale of the present study is to develop a combination based on the pharmacokinetics
and mechanisms of action of the agents paclitaxel plus gemcitabine and cisplatin, which are
all known active agents in urothelial tumors. Gemcitabine may be synergistic with
DNA-damaging drugs such as paclitaxel and cisplatin because it can antagonize DNA repair.
Investigators will investigate the combination in this Phase II study.

Overal Status Start Date Phase Study Type
Recruiting Start Date: October 2015 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Efficacy as measured by the Objective Response Rate (ORR)

Primary Outcome 1 - Time Frame: Participants will be followed until disease progression, an expected average of 18 months.

Condition:

  • Urinary Bladder Neoplasms

Eligibility

Criteria:
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Robert J Amato, DO

Role: Principal Investigator

Affiliation: The University of Texas Health Science Center, Houston

Overall Contact

Name: Christine M Kent, MSN, RN

Phone: 832-325-6515

Email: Christine.M.Kent@uth.tmc.edu

Location

Facility Status Contact
UTHealth Memorial Hermann Cancer Center
Houston, Texas 77030
United States
Recruiting