MDACC Study Summary 2003-0874

Study Summary
No. 2003-0874:.......Anus......Cathy Eng......Gastrointestinal Medical Oncology

Study Summary Title



Study Summary Number:	2003-0874

Study Title:	A Phase II Study of Capecitabine (Xeloda) /Oxaliplatin (Eloxatin) with Concomitant Radiotherapy (XRT), XELOX-XRT, in Squamous Cell Carcinoma of the Anal Canal

Physician

New Patient Referral



Name:	Cathy Eng	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

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

Phone:	713-792-2828 Contact us about clinical trials

General Information



Disease Group:	Anus	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Patients must remain at MDACC for treatment Monday-Friday for the 7 weeks of treatment.

Treatment Agents:	Capecitabine Oxaliplatin Radiation	Home Care:	No treatment may be given in the local community.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Hospitalization is not required for this study.


Description/ Intervention:	The goal of this clinical research study is to find out how effective treatment with oxaliplatin, capecitabine, and radiation is against cancer of the anal canal. The safety of this treatment will also be studied.

Study Objectives / Outcomes

Primary Objectives

To determine time to treatment failure and treatment-related toxicities experienced when capecitabine is combined with oxaliplatin and concomitant XRT.

Secondary Objectives

To determine the complete response (CR) rate to XELOX-XRT

To determine local regional control (LRC) at 2 years

To determine colostomy-free survival at 2 years

To determine the median overall survival (OS) at 2 years

To determine the progression-free survival (PFS) at 2 years

Study Status Information



Study Activation / Registration Date:	04/16/2004

IRB Review and Approval Date:	12/03/2003

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	71

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) Previously untreated patients with histologically proven squamous cell carcinoma of the anal canal.

2) AJCC stage II-IIIB (TX 1-4, NX, MO).

3) Age >/= 16 yrs old.

4) ECOG PS 0-1 (Appendix A).

5) Adequate organ function including: Absolute neutrophil Count (ANC) >/= 1,500/uL, Platelets >/= 100,000/uL, Total bilirubin </= 1.5 x ULN, AST (SGOT)/ALT (SGPT) </= 3 x ULN, Creatinine </= 1.5mg/dL or Creatinine Clearance (CrCL) >/= 50 cc/min.

6) Patients may have measurable or non-measurable disease. Patients with measurable disease, as defined by the modified RECIST criteria, have at least one lesion that can be accurately measured in at least one dimension with longest diameter to be recorded >/= 20 mm using conventional techniques or >/= 10 mm with spiral CT scan (with minimum lesion size no less than double the slice thickness). Lesions seen on colonoscopy or barium studies are not considered measurable lesions.

7) A negative pregnancy test in all women of child-bearing potential, within two weeks of initiating treatment.

8) The effects of oxaliplatin and capecitabine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because cytotoxic agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

9) Ability to understand and the willingness to sign the written informed consent/authorization document.

Exclusion Criteria:

1) Prior chemotherapy with oxaliplatin, capecitabine, or 5-fluorouracil.

2) Prior radiation to the pelvis.

3) Prior surgery for anal cancer excluding prior biopsy.

4) Known history of dihydropyrimidine (DPD) deficiency.

5) Known history of hypersensitivity to platinum-containing compounds.

6) Peripheral neuropathy of >/= grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) 3.0.

7) Calculated creatinine clearance (CrCl) < 50 cc/min.

8) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit adherence with study requirements.

9) Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation.

10) Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with oxaliplatin or capecitabine, breast feeding should be discontinued.

11) Because of the known interaction of capecitabine and coumadin, patients taking coumadin will be ineligible. Patients will be requested to discontinue coumadin and utilize Lovenox if agreeable. Patients must have discontinued coumadin for 7 days before initiating therapy.

12) No prior malignancies (excluding non-melanomatous skin neoplasms) over the past 5 years.

13) HIV-positive patients receiving combination anti-retroviral therapy are excluded from this study because of possible pharmacokinetic interactions with capecitabine or oxaliplatin. This exclusion is for patient safety since patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, and because very few HIV-positive anal canal cancer patients are seen at this institution. This hinders us from accruing enough patients to adequately test the safety of this regimen in this population.

14) Patients with symptomatic pulmonary fibrosis.

Links

Registration Number: NCT00093379
Study Information on Clinical Trials Registry (clinicaltrials.gov)