Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer

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Brief Title

Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer

Official Title

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

Brief Summary

      RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in
      different ways to stop tumor cells from dividing so they stop growing or die. Capecitabine
      may stop the growth of tumor cells by stopping blood flow to the tumor. Radiation therapy
      uses high-energy x-rays to damage tumor cells. Capecitabine and oxaliplatin may make tumor
      cells more sensitive to radiation therapy. Combining capecitabine and oxaliplatin with
      radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin
      together with radiation therapy works in treating patients with stage II or stage III anal
      cancer.
    

Detailed Description

      OBJECTIVES:

      Primary

        -  Determine time to treatment failure in patients with stage II-IIIB squamous cell
           carcinoma of the anal canal treated with capecitabine, oxaliplatin, and radiotherapy
           (i.e. Capecitabine (Xeloda)/Oxaliplatin (Eloxatin) With Concomitant Radiotherapy (XRT)
           shortened to XELOX/XRT).

        -  Determine the toxic effects of this regimen in these patients.

      Secondary

        -  Determine the complete response rate in patients treated with this regimen.

        -  Determine 2-year local regional control in patients treated with this regimen.

        -  Determine 2-year colostomy-free survival in patients treated with this regimen.

        -  Determine 2-year median overall survival in patients treated with this regimen.

        -  Determine 2-year progression-free survival in patients treated with this regimen.

      OUTLINE: Patients receive oral capecitabine* twice daily on days 1-2, 6-10, 20-24, 27-31, and
      41-42, and undergo radiotherapy* once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38,
      and 41-42. Patients also receive oxaliplatin intravenous (IV) over 2 hours on days 1, 8, 22,
      and 29. Treatment continues in the absence of disease progression or unacceptable toxicity.

      NOTE: *Patients with T3-4 lesions also receive oral capecitabine twice daily and undergo
      radiotherapy once daily on days 43 and 44.

      Patients are followed at 4-6 and 12 weeks and then periodically thereafter.

      PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

2 Year Failure Free Survival

Secondary Outcome

 Number of Participants With Complete Response at 2 Years

Condition

Anal Cancer

Intervention

Capecitabine

Study Arms / Comparison Groups

 Capecitabine + Oxaliplatin + XRT
Description:  Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

April 2004

Completion Date

July 2012

Primary Completion Date

July 2012

Eligibility Criteria

        Inclusion Criteria:

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

          2. American Joint Committee on Cancer (AJCC) stage II-IIIB (TX 1-4, NX, MO).

          3. Age >/= 16 yrs old.

          4. Eastern Cooperative Oncology Group (ECOG) Performance Scale (PS) 0-1.

          5. Adequate organ function including: Absolute neutrophil Count (ANC) >/= 1,500/uL,
             Platelets >/= 100,000/uL, Total bilirubin /= 50 cc/min.

          6. Patients may have measurable or non-measurable disease. Patients with measurable
             disease, as defined by the modified Response Evaluation Criteria in Solid Tumors
             (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 intravenous (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.
      

Gender

All

Ages

16 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Cathy Eng, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00093379

Organization ID

2003-0874

Secondary IDs

P30CA016672

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Cathy Eng, MD, Study Chair, M.D. Anderson Cancer Center


Verification Date

March 2014