Studying Biomarkers in Tumor Tissue and Blood Samples From Patients Undergoing Chemotherapy and Radiation Therapy for Stage II or Stage III Rectal Cancer That Can Be Removed By Surgery

• Status: Withdrawn
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.

PURPOSE: This phase I trial is studying biomarkers in tumor tissue and blood samples from patients undergoing chemotherapy and radiation therapy for stage II or stage III rectal cancer that can be removed by surgery.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the rectum

• Inferior margin within 16 cm of the anal verge on endoscopic exams

• Locally advanced or low lying disease meeting 1 of the following stage criteria:

• Stage II (T2, N0, M0) disease

• Distal tumor (< 5 cm from anal verge) invades into muscularis propria but not beyond (T2)

• Stage II (T3-4, N0, M0) disease

• Tumor invades through muscularis propria into subserosa or into non-peritonealized pericolic or perirectal tissues (T3) OR tumor directly invades other organs or structures and/or perforates visceral peritoneum (T4)

• Stage III (any T, N1-2, M0) disease

• Tumor has invaded to any depth with involvement of regional lymph nodes (N1-2)

• Resectable disease

• No suspicious metastatic disease (M1)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Adequate organ function

• No significant co-morbidities that would preclude the use of neoadjuvant chemoradiotherapy, including any of the following:

• Severe heart failure

• Arrhythmia

• Significant liver or kidney dysfunction

• No psychiatric or addictive disorder that would preclude study compliance

• No bleeding diathesis

• No contraindication for sigmoidoscopy

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy or chemotherapy for rectal cancer

• No concurrent warfarin unless appropriate bridging therapy is arranged during biopsy procedures