Oxaliplatin, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Rectum

NCT00086931 | Completed Phase 1 DMC

• 3 other identifiers: I 10803RPCI-I-10803SANOFI-RPCI-I-10803
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and capecitabine may make tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase I/II trial is studying the side effects and best dose of oxaliplatin and capecitabine when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for locally advanced cancer of the rectum. NOTE: \*The phase I portion of this trial closed 06/2005. The best dose of oxaliplatin and capecitabine has been determined.

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the rectum; stage III rectal cancer; stage II rectal cancer

Outcome Measures

Primary Outcomes (1)

• Complete pathological response rate at time of surgery

  Time of surgery

Secondary Outcomes (1)

• Disease-free survival, safety, and overall survival at 5 years

  Continuous

Interventions

capecitabine DRUG

oral dose escalating, twice daily.

oxaliplatin DRUG

IV over 2 hours on days 1, 8, 15, 22, and 29.

conventional surgery PROCEDURE

curative-intent surgery 6-8 weeks after the completion of chemoradiotherapy

neoadjuvant therapy PROCEDURE

chemotherapy and radiation prior to surgery

radiation therapy RADIATION

once daily 5 days a week for 5.5 weeks

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the rectum * Tumor involving the distal 12 cm of the rectum (above the anal verge) * Clinically staged by endoscopic ultrasound with one of the following criteria: * T3-T4 disease * Evidence of lymph node involvement, defined by the presence of ≥ 1 enlarged peri-rectal lymph node (≥ 1 cm in size) * No known distant metastases PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * ECOG 0-1 OR * Karnofsky 70-100% Life expectancy * More than 1 year Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin normal * AST and ALT ≤ 2.5 times upper limit of normal Renal * Creatinine normal OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Able to receive oral medication * No other malignancy within the past 5 years except nonmelanoma skin cancer * No prior or concurrent significant neuropathy * No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs * No ongoing or active infection * No other concurrent uncontrolled illness * No psychiatric illness or social situation that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-method contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent granulocyte-stimulating factors Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior pelvic radiotherapy Surgery * Not specified Other * No other concurrent investigational agents * No other concurrent anticancer agents or therapies

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Related Publications (2)

• Fakih MG, Bullarddunn K, Yang GY, Pendyala L, Toth K, Andrews C, Rustum YM, Ross ME, Levea C, Puthillath A, Park YM, Rajput A. Phase II study of weekly intravenous oxaliplatin combined with oral daily capecitabine and radiotherapy with biologic correlates in neoadjuvant treatment of rectal adenocarcinoma. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):650-7. doi: 10.1016/j.ijrobp.2008.01.020. Epub 2008 Jun 17.

  PMID: 18565686 RESULT

• Fakih MG, Rajput A, Yang GY, et al.: A phase I and biological correlates study of capecitabine (CAP) + oxaliplatin (OX) + radiation therapy (RT) in locally advanced rectal cancer (LARC). [Abstract] J Clin Oncol 23 (Suppl 16): A-3633, 279s, 2005.

  RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Interventions

Capecitabine; Oxaliplatin; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal 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; Combined Modality Therapy; Therapeutics

Study Officials

• Marwan Fakih, MD

  Roswell Park Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: September 1, 2003
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2010
• Last Updated: March 8, 2013

Record last verified: 2013-03

Locations

US (1)