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

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00093379

Purpose

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.

Condition	Intervention	Phase
Anal Cancer	Drug: capecitabine Drug: oxaliplatin Procedure: radiation therapy	Phase II

MedlinePlus related topics: Anal Cancer Cancer

Drug Information available for: Capecitabine Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Time to treatment failure [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Complete response rate [ Designated as safety issue: No ]
2-year local regional control [ Designated as safety issue: No ]
2-year colostomy-free survival [ Designated as safety issue: No ]
2-year median overall survival [ Designated as safety issue: No ]
2-year progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment:	71
Study Start Date:	April 2004

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.
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 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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed squamous cell carcinoma of the anal canal
- Stage II-IIIB (TX1-4, NX, M0) disease
Previously untreated disease
Measurable or nonmeasurable disease

PATIENT CHARACTERISTICS:

Age

16 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST and ALT ≤ 3.0 times ULN

Renal

Creatinine ≤ 1.5 mg/dL OR
Creatinine clearance ≥ 50 mL/min

Cardiovascular

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia

Pulmonary

No symptomatic pulmonary fibrosis

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No peripheral neuropathy ≥ grade 2
No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
No known dihydropyrimidine deficiency
No known hypersensitivity to platinum-containing compounds
No ongoing or active infection
No psychiatric illness or social situation that would preclude study participation
No other malignancy within the past 5 years except nonmelanoma skin cancer
No other uncontrolled illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

At least 24 hours since prior colony-stimulating factors
No prior biologic therapy
No concurrent immunotherapy

Chemotherapy

No prior chemotherapy
No concurrent chemotherapy

Endocrine therapy

No concurrent hormonal therapy

Radiotherapy

No prior radiotherapy to the pelvis

Surgery

No prior surgery for anal cancer except biopsy

Other

No concurrent warfarin
No concurrent combination antiretroviral therapy for HIV-positive patients
No concurrent alternative medicine vitamin supplements unless approved by the treating medical oncologist
No other concurrent anticancer therapy, including experimental medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093379

Locations

United States, Texas
M. D. Anderson Cancer Center at University of Texas	Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Study Chair:	Cathy Eng, MD	M.D. Anderson Cancer Center
Investigator:	Christopher H. Crane, MD	M.D. Anderson Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000380771, MDA-2003-0874, SANOFI-MDA-2003-0874
Study First Received:	October 6, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00093379
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage II anal cancer
stage IIIA anal cancer
stage IIIB anal cancer
squamous cell carcinoma of the anus

Study placed in the following topic categories:

Capecitabine
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Squamous cell carcinoma
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Rectal neoplasm
Carcinoma
Epidermoid carcinoma

Oxaliplatin
Digestive System Diseases
Carcinoma, squamous cell
Gastrointestinal Neoplasms
Anal cancer
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Rectal cancer
Anus Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Neoplasms by Site

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Anus Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009