MDACC Study Summary 2008-0415

Study Summary
No. 2008-0415:.......Bladder......Arlene Siefker-Radtke......Genitourinary Medical Oncology

Study Summary Title



Study Summary Number:	2008-0415

Study Title:	Phase II Randomized Trial of Gemcitabine and Cisplatin with or without Cetuximab in Patients with Urothelial Carcinoma

Physician

New Patient Referral



Name:	Arlene Siefker-Radtke	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Genitourinary Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2830 Contact us about clinical trials

General Information



Disease Group:	Bladder	Supported By:	Bristol-Myers Squibb Company ImClone Systems Inc. National Comprehensive Cancer Network - University of Michigan Lead Site

Phase of Study:	Phase II	Return Visit:	Participants will return to clinic weekly for blood testing and gemcitabine infusions for the first 3 weeks of each 4 week cycle. Cisplatin will be given on Day 1 of each cycle. Patients in Arm B will recieve Cetuximab on Day 1 and 15 of each cycle.

Treatment Agents:	Cetuximab Cisplatin Gemcitabine	Home Care:	N/A

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to compare the effectiveness of gemcitabine hydrochloride and cisplatin when given with or without cetuximab to patients with bladder cancer. The safety of these combinations will also be studied.

Study Objectives / Outcomes

Primary Objective:

The primary objective of the study is to compare the overall response rate of combination gemcitabine and cisplatin with or without cetuximab in patients with locally advanced or metastatic urothelial carcinoma.

Secondary Objectives:
To assess:

The safety and tolerability of cetuximab in combination with cisplatin and gemcitabine.
Response duration.
The progression-free survival and overall survival of both treatment groups.
Whether cetuximab will sensitize non-responding patients to combination gemcitabine and cisplatin.
Correlated levels of D-Dimer and C-Reactive protein with risk of vascular thromboembolic events (VTE).

Study Status Information



Study Activation / Registration Date:	01/20/2009

IRB Review and Approval Date:	08/21/2008

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	86

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Male and female patients at least 18 years of age.

2) Histologic / cytologic diagnosis of urothelial carcinoma (transitional cell carcinoma; either pure or mixed histology) that is metastatic, locally recurrent, or unresectable (T4bN0 or any T, N2-3).

3) Patients must have measurable disease by radiologic imaging.

4) If patients received radiation therapy they must have recovered from side effects and must not have had more than 25% of the bone marrow irradiated.

5) Eastern Cooperative Oncology Group (ECOG) performance status of </= 2

6) Life expectancy of at least 12 weeks.

7) No prior malignancy is allowed except: Adequately treated basal cell or squamous cell skin cancer or; In situ carcinoma of any site or; Other adequately treated malignancy for which the patient is currently disease free for at least one year; Patients with prostate cancer diagnosed at the time of cystectomy who have an undetectable PSA without hormonal therapy will be eligible.

8) Patients must have adequate organ and marrow function as defined below obtained within 14 days prior to registration. 1.) absolute neutrophil count >/= 1,500/microL; 2.) platelets >/= 100,000/microL; 3.) total bilirubin </= 1.5 mg/DL; 4.) Serum creatinine </= 1.5 mg/DL OR; 5.) Creatinine clearance >/= 50 mL/min as calculated by Cockroft-Gault method

9) Timing guideline for pre-study labs and measurements: a.) All pre-study labs required for determination of eligibility are to be completed within 14 days prior to registration. b.) X-rays and/or scans to assess all disease sites are to be completed within 1 month prior to registration (or the next business day if falls on a weekend or holiday).

10) All patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and federal guidelines.

11) Men and women of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

1) Patients may not have received previous systemic chemotherapy for the current stage of disease with the following exception: Prior neoadjuvant or adjuvant chemotherapy is allowed provided it has been at least 6 months since treatment with non-cisplatin containing regimens and >/= 1 year since treatment with a cisplatin containing regimen.

2) Prior therapy targeting the epidermal growth factor receptor (EGFR) pathway

3) History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan.

4) Known HIV - positive patients may not participate. This is to avoid additional complications that immune suppression and HIV infection may cause due to the intense nature of the chemotherapy in this trial.

5) History of congestive heart failure (CHF) or chronic renal failure, active TIAs, recent (in the last 6 months) stroke, symptomatic pulmonary embolus (PE), or myocardial infarction.

6) Patients with history of DVT or incidental or asymptomatic PE will be eligible for the study as deemed appropriate by the treating physician provided they continue prophylactic or full dose anticoagulation as per standards of care for the specific event.

7) Prior grade 3 or 4 severe infusion reaction to monoclonal antibodies.

8) Concurrent treatment on another therapeutic clinical trial. Supportive care trials or non-treatment trials, e.g. Quality of Life (QOL), are allowed.

9) Pregnancy or breastfeeding. Female subjects must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to registration. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.

10) Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.

11) Patients who are allergic to aspirin will be excluded.

Links

Registration Number: NCT00645593
Study Information on Clinical Trials Registry (clinicaltrials.gov)