Clinical Trial Of Neoadjuvant Chemotherapy (NAC)In Upper Tract Urothelial Carcinoma (UTUC)

NCT01663285 | Terminated Phase 2 Results DMC

• 2 other identifiers: UMCC 2012.038HUM00062285
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

Brief Summary

The main purpose of this study is to look at the cancer-free survival at two years of subjects with high risk upper tract urothelial cancer when treated with the combination of two chemotherapy drugs called Gemcitabine and Cisplatin followed by surgery to remove the kidney, all or part of the ureter (ureters are tubes made of smooth muscle fibers that propel urine from the kidneys to the urinary bladder), and a cuff of bladder where the ureter drains into the bladder. Other purposes of the study include looking at the safety of Gemcitabine and Cisplatin before surgery for this type of cancer, time to recurrence of cancer, and overall survival. Exploratory integrative tumor sequencing: The purpose of this part of the study is to test deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) in various types of samples (tissue and blood) to detect different types of cancer genetic changes in upper tract urothelial cancer (UTUC) to help develop future studies in UTUC. DNA and RNA contain key instructions for cell function and help determine the characteristics of each individual such as hair, eye, and skin color, height, susceptibility to diseases, and other characteristics.

Conditions

Urothelial Cancer; Bladder Cancer

Keywords

Urothelial; Bladder; Cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence-free Survival Time

  The 2-year recurrence-free survival (RFS) time for patients treated with neoadjuvant cisplatin and gemcitabine chemotherapy followed by surgery in high risk upper tract urothelial carcinoma.

  2 years after participant surgery

Secondary Outcomes (2)

• Number of Patients With Pathologic T0/Tis/Ta N0.

  51 months

• Number of Participants With Adverse Events

  9 years

Study Arms (1)

Neoadjuvant Gemcitabine and Cisplatin

EXPERIMENTAL

Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.

Drug: Neoadjuvant Cisplatin and Gemcitabine

Interventions

Neoadjuvant Cisplatin and Gemcitabine DRUG

Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.

Neoadjuvant Gemcitabine and Cisplatin

Eligibility Criteria

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

You may qualify if:

• Patients must have HIGH GRADE upper tract urothelial carcinoma
• Patients must be considered to be a candidate for surgery with curative intent (nephroureterectomy or distal ureterectomy) with lymph node dissection by the treating urologist at baseline within 42 days prior to registration.
• Patients must be able to care for themselves and must be up and about more than 50% of waking hours
• All patients must be evaluated by a medical oncologist at baseline within 42 days prior to registration. Patients must be considered to be a candidate for cisplatin-based neoadjuvant chemotherapy by a medical oncologist at baseline and must have adequate kidney function and any pre-existing peripheral neuropathy must be moderate to mild.
• Prior uro-oncologic history:
• History of or active non-invasive carcinoma or carcinoma in situ of the bladder or upper tract is allowed.
• Patients may have received prior intravesical chemotherapy or immunotherapy such as BCG.
• Prior neoadjuvant chemotherapy for bladder cancer or invasive contralateral upper tract cancer is allowed.
• Prior adjuvant chemotherapy for bladder cancer or invasive contralateral upper tract cancer is allowed but must have been completed ≥2 years prior to study registration.
• Patients must have adequate organ and bone marrow function as determined by screening tests
• Patients must have recovered from any reversible toxicities of prior procedure or surgery
• Patients must be 18 years or older on date of registration
• All patients must be informed of the investigational nature of this study and must sign an informed consent document

You may not qualify if:

• Patients must have no evidence of regional lymphadenopathy or distant metastasis on imaging.
• No history of invasive or node positive or metastatic bladder cancer or invasive contralateral upper tract cancer within 2 years prior to registration.
• Patients with one kidney are not eligible
• Patients may not be enrolled in another interventional clinical trial at the time of registration.
• No prior non-urothelial malignancy is allowed, except for cancer from which the patient has been disease free for at least 1 year at the discretion of the treating oncologist. History of adequately treated (at the discretion of the treating oncologist) basal cell or squamous cell skin cancer or in situ cervical cancers is allowed.
• Pregnant or lactating women are not eligible. Women/men of reproductive potential must agree to use an effective contraceptive method. Women with reproductive potential must have a negative pregnancy test within 14 days prior to registration.
• Patients must not have any other medical condition(s) that make(s) their participation in the study unadvisable in the opinion of the treating oncologist.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (3)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

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)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

The study was terminated prematurely due to poor patient accrual. Study objectives were not analyzed.

Results Point of Contact

• Title: Dr. Ajjai Alva
• Organization: University of Michigan Comprehensive Cancer Center

ajjai@umich.edu

734-647-8921

Study Officials

• Ajjai S. Alva, M.D.

  University of Michigan

  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: SPONSOR

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: August 13, 2012
• Study Start: September 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: December 3, 2015
• Results First Posted: September 18, 2014

Record last verified: 2015-11

Locations

US (3)