Evaluation of Oxaliplatin and Gemcitabine in Patients With Metastatic Bladder Cancer

NCT04039867 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 20043920NCI-2011-01249
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial evaluated the impact of Oxaliplatin and Gemcitabine in patients with recurrent or advanced transitional cell carcinoma of the bladder. The combination of Oxaliplatin and Gemcitabine is considered investigational and this study will help in determining if their activity and toxicity profiles are comparable or better than the standard regimens.

Conditions

Carcinoma, Transitional Cell

Keywords

Carcinoma, Transitional Cell; Bladder Cancer; oxaliplatin; Gemcitabine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events to Evaluate Tolerability of Oxaliplatin With Gemcitabine

  To evaluate the tolerability of administering Oxaliplatin in combination with gemcitabine in patients with recurrent or advanced TCC bladder. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0.

  From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year.

Secondary Outcomes (2)

• Overall Response Rate as Assessed by RECIST Criteria of Patients Who Received Gemcitabine and Oxaliplatin

  From date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.

• Overall Survival of Patients Who Received Gemcitabine and Oxaliplatin

  From date of registration for 5 years or until death from any cause, whichever came first.

Study Arms (1)

Oxaliplatin with Gemcitabine

EXPERIMENTAL

Oxaliplatin will be given as an intravenous infusion over 60 minutes on Days 1 and 14 at a dose of 100 mg/m2 for each cycle. Gemcitabine (1000 mg/m2) will be given on days 1 and 14 as an intravenous infusion over 30 minutes immediately prior to Oxaliplatin.

Drug: Oxaliplatin with Gemcitabine

Interventions

Oxaliplatin with Gemcitabine DRUG

Oxaliplatin will be given as an intravenous infusion over 60 minutes on Days 1 and 14 at a dose of 100 mg/m2 for each cycle. Gemcitabine (1000 mg/m2) will be given on days 1 and 14 as an intravenous infusion over 30 minutes immediately prior to Oxaliplatin.

Also known as: Gemzar, Eloxatin

Oxaliplatin with Gemcitabine

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 histologically or cytologically confirmed diagnosis of transitional cell carcinoma of the bladder.
• Patients must have metastatic or locally recurrent transitional cell carcinoma of the bladder. Patients with locoregional disease must be considered incurable by means of locoregional therapy.
• All sites of disease must be assessed and designated as measurable or non- measurable disease as documented by CT, MRI, X-ray physical exam or nuclear exam. All measurable disease must be assessed within 28 days prior to registration. All non-measurable disease must be assessed within 42 days prior to registration.
• Patients must not have more than one prior chemotherapy regimen for recurrent/metastatic disease. Patients with initial locally advanced but nonmetastatic disease are allowed to have one prior chemotherapy regimen as part of the primary curative therapy. All chemotherapy must be completed 4 weeks prior to registration. Any number of prior biologic therapies (e.g. chimeric antibodies or kinase inhibitors) is permitted as part of the chemotherapy regimen.
• Patients may have received prior radiotherapy if there has been complete recovery from all radiation-induced toxicities. At least 4 weeks must have elapsed from the completion of radiation therapy to the time of registration. If lesions within the radiation port are to be used to assess response to therapy, those lesions must have demonstrated clear progression by the criteria outlined in Section 10.1.2V following completion of radiation therapy.
• Patients must not have a surgical procedure for bladder cancer within 4 weeks prior to registration. Patients must have completely recovered from all surgery prior to registration.
• Patients must have adequate bone marrow reserve as evidenced by ANC \> 1,500 μl and platelets \> 100,000/ μl obtained within 14 days prior to registration.
• Patients must have adequate hepatic function as evidenced by serum bilirubin \<1.5x the institutional upper limit of normal. Serum transaminase (SGOT or SGPT) be must \< 1.5 x the institutional upper limit of normal serum unless the liver is involved with tumor, in which case serum transaminase (SGOT or SGPT) must be \< 5 x the institutional limit of normal. These tests must be obtained within 14 days prior to registration.
• Patients must have a creatinine \< 2 x the institutional upper limit of normal obtained within 14 days prior to registration.
• All patients must be 18 years of age or older.
• Patients must have a Zubrod performance of 0-2.
• Patients must not have prior therapy with Oxaliplatin or Gemcitabine.

You may not qualify if:

• Patients with severe psychiatric disorder are not eligible.
• Patients with known brain metastasis are not eligible. However, brain imaging studies are not required for eligibility if the patient has no neurological signs or symptoms. If brain imaging studies are performed, they must be negative for disease.
• No other prior malignancy is allowed except for adequately treated basal cell or squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and II cancer from which the patient is in complete remission, or any other malignancy from which the patient has been disease-free for 5 years.
• Patients with any evidence of active or uncontrolled infection, recent myocardial infarction, unstable angina, or life-threatening arrhythmia are not eligible.
• Patients with any evidence of active or uncontrolled infection, recent myocardial infarction, unstable angina, or life-threatening arrhythmia are not eligible.
• Patients with severe psychiatric disorder are not eligible.
• Patients with known brain metastasis are not eligible. However, brain imaging studies are not required for eligibility if the patient has no neurological signs or symptoms. If brain imaging studies are performed, they must be negative for disease.
• No other prior malignancy is allowed except for adequately treated basal cell or squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and II cancer from which the patient is in complete remission, or any other malignancy from which the patient has been disease-free for 5 years.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Urinary Bladder Neoplasms

Interventions

Oxaliplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

The main limitation for our study was the small sample size.

Results Point of Contact

• Title: UC Irvine Health / Chao Family Comprehensive Cancer Center
• Organization: UC Irvine Health / Chao Family Comprehensive Cancer Center

ucstudy@uci.edu

1-877-UC-STUDY

Study Officials

• John P Fruehauf, MD, PhD

  University of California, Irvine

  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: Professor of Clinical Medicine

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: July 31, 2019
• Study Start: January 20, 2005
• Primary Completion: October 6, 2011
• Study Completion: October 6, 2011
• Last Updated: August 21, 2023
• Results First Posted: January 2, 2020

Record last verified: 2023-08

Locations

US (1)