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

NCT00093379 | Completed Phase 2 Results

• 5 other identifiers: 2003-0874P30CA016672MDA-2003-0874SANOFI-MDA-2003-0874CDR0000380771
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Cancer

Keywords

stage II anal cancer; stage IIIA anal cancer; stage IIIB anal cancer; squamous cell carcinoma of the anus; Capecitabine; Xeloda; Oxaliplatin; Eloxatin; Radiotherapy; XRT

Outcome Measures

Primary Outcomes (1)

• 2 Year Failure Free Survival

  Treatment failure defined as: Biopsy proven residual disease identified 12 -14 weeks after the conclusion of chemoradiation therapy, Treatment-related mortality or Disease recurrence.

  2 years

Secondary Outcomes (5)

• Number of Participants With Complete Response at 2 Years

  2 Years

• Number of Participants With 2-year Colostomy-Free Survival

  2 Years with median study follow up of 19 months

• 2-year Local Regional Control

  2 Years

• 2-Year Median Overall Survival

  2 Years

• Number of Participants With Progression-Free Survival at 2-Year

  2 Years

Study Arms (1)

Capecitabine + Oxaliplatin + XRT

EXPERIMENTAL

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.

Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Radiation Therapy (XRT)

Interventions

Capecitabine DRUG

825 mg/m\^2 orally twice a day (BID), Mon-Fri during weeks 1, 2, 4, and 5.

Also known as: Xeloda

Capecitabine + Oxaliplatin + XRT

Oxaliplatin DRUG

50 mg/m\^2 by vein (IV) over 2 hours on days 1, 8, 22, and 29.

Also known as: Eloxatin

Capecitabine + Oxaliplatin + XRT

Radiation Therapy (XRT) RADIATION

Undergo radiotherapy\* once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. \*Patients with T3-4 lesions undergo radiotherapy once daily on days 43 and 44.

Also known as: XRT, RT, Radiotherapy

Capecitabine + Oxaliplatin + XRT

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated patients with histologically proven squamous cell carcinoma of the anal canal.
• American Joint Committee on Cancer (AJCC) stage II-IIIB (TX 1-4, NX, MO).
• Age \>/= 16 yrs old.
• Eastern Cooperative Oncology Group (ECOG) Performance Scale (PS) 0-1.
• Adequate organ function including: Absolute neutrophil Count (ANC) \>/= 1,500/uL, Platelets \>/= 100,000/uL, Total bilirubin \</= 1.5 \* upper limit of normal (ULN), aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) \</= 3 \* ULN, Creatinine \</= 1.5mg/dL or Creatinine Clearance (CrCL) \>/= 50 cc/min.
• 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.
• A negative pregnancy test in all women of child-bearing potential, within two weeks of initiating treatment.
• 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.
• Ability to understand and the willingness to sign the written informed consent/authorization document.

You may not qualify if:

• Prior chemotherapy with oxaliplatin, capecitabine, or 5-fluorouracil.
• Prior radiation to the pelvis.
• Prior surgery for anal cancer excluding prior biopsy.
• Known history of dihydropyrimidine (DPD) deficiency.
• Known history of hypersensitivity to platinum-containing compounds.
• Peripheral neuropathy of \>/= grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) 3.0.
• Calculated creatinine clearance (CrCl) \< 50 cc/min.
• 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.
• Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation.
• 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.
• 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.
• No prior malignancies (excluding non-melanomatous skin neoplasms) over the past 5 years.
• Patients with symptomatic pulmonary fibrosis.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

• Eng C, Jacome AA, Das P, Chang GJ, Rodriguez-Bigas M, Skibber JM, Wolff RA, Qiao W, Xing Y, Sethi S, Ohinata A, Crane CH. A Phase II Study of Capecitabine/Oxaliplatin With Concurrent Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Anal Canal. Clin Colorectal Cancer. 2019 Dec;18(4):301-306. doi: 10.1016/j.clcc.2019.06.003. Epub 2019 Jul 2.

  PMID: 31350201 DERIVED

MeSH Terms

Conditions

Anus Neoplasms

Interventions

Capecitabine; Oxaliplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Therapeutics

Results Point of Contact

• Title: Cathy Eng, MD/ Professor
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Cathy Eng, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

• Christopher H. Crane, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: October 6, 2004
• First Posted: October 8, 2004
• Study Start: April 1, 2004
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 18, 2023
• Results First Posted: April 17, 2014

Record last verified: 2023-03

Locations

US (1)