Capecitabine,Oxaliplatin & Erbitux Given Throughout Multi-Modal Therapy for Locally Advanced Rectal Adenocarcinoma

NCT00353457 | Terminated Phase 2 DMC

• 2 other identifiers: 803437UPCC 09204
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase II study of induction chemotherapy (capecitabine, oxaliplatin and cetuximab (erbitux)) followed by capecitabine, oxaliplatin, cetuximab and radiotherapy followed by surgery followed by adjuvant capecitabine, oxaliplatin and cetuximab for locally advanced resectable rectal cancer.

Conditions

Rectal Cancer

Keywords

Adjuvant therapy; Rectal cancer; Capecitabine; Oxaliplatin; Cetuximab; Erbitux

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response

  After neoadjuvant treatment

Secondary Outcomes (3)

• Sphincter function

  After surgery

• Type of surgery

  At time of surgery

• Disease free survival

  From time of study entry until first documented relapse

Study Arms (1)

Arm 1

EXPERIMENTAL

Capecitabine, Oxaliplatin and Cetuximab

Drug: Capecitabine, Oxaliplatin and Cetuximab; Radiation: Radiation

Interventions

Capecitabine, Oxaliplatin and Cetuximab DRUG

Capecitabine 825mg/m2 po BID D1-15 of 21 x2 cycles (Cyle 1 and 2), Capecitabine 825mg/m2 po BID weekly Sun PM-Fri AM x2 cycles (cycle 3 and 4), Capecitabine 825mg/m2 po BID D1-15 of 21 x4 cycles (cycle 5,6,7,8) Oxaliplatin 130mg/m2 IV Day 1 every 3 weeks x2 cycles (Cycle 1 and 2), Oxaliplatin 50mg/m2 IV weekly every Monday x2 cycles (Cycle 3 and 4), Oxaliplatin 130mg/m2 IV day 1 every 3 weeks x4 cycles (Cycles 5,6,7,8) Cetuximab 400mg/m2 IV cycle 1 day1, Cetuximab 250mg/m2 Day 1,8,15 of 21 for cycles 1-8

Arm 1

Radiation RADIATION

45 Gy in 25 fractions, 3-fraction boost 5.4 Gy

Arm 1

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed nonmetastatic, measurable, locally advanced (T3 or T4) rectal adenocarcinoma
• If available, tumor tissue must be sent for investigational immunohistochemical evaluations of EGFR status
• The distal border of the tumor must be at or below the peritoneal reflection (defined a with 12 cm of the anal verge by proctoscopy)
• Transmural penetration of the tumor demonstrated by CT + endorectal ultrasound or MRI
• ECOG PS 0-2
• No prior chemotherapy, biologic therapy or radiation therapy
• Age \>= 18 years old
• Laboratory values: ANC \>= 1500/mm3; Platelets \>= 100,000/mm3; Hgb \>= 9 g/dL; Estimated CrCl \> 50 mL/min; Serum bilirubin \<= 1.5 x ULN; AST and ALT \<= 3.0 x ULN; Negative proteinuria based on dip stick reading
• Patients must either be not of child bearing potential or have a negative pregnancy test upon study enrollment. Patients must agree to continue contraception for 30 days from the date of the last study drug administration.

You may not qualify if:

• Pregnant or lactating woman. Women of childbearing potential with either a positive or no pregnancy test upon study enrollment. Women/men of childbearing potential not using a reliable and appropriate contraceptive method. Patients must agree to continue contraception for 30 days from the date of the last study administration.
• Life expectancy \< 3 months
• Serious, uncontrolled, concurrent infection(s)
• Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs \< 4 weeks prior to randomization.
• Prior therapy which specifically and directly targets the EGFR pathway.
• Prior severe infusion reaction to a monoclonal antibody
• Any prior therapy with Oxaliplatin
• Prior pelvic irradiation for any reason
• Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil or known DPD deficiency
• Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
• Participation in any investigational drug study within 4 weeks preceding the start of the study treatment
• Major surgery within 4 weeks of the study treatment, without complete recovery
• Known, existing uncontrolled coagulopathy
• Unwillingness to give written informed consent
• Unwillingness to participate or inability to comply with the protocol for the duration of the study

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Bristol-Myers Squibb: collaborator
• Roche Pharma AG: collaborator

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine; Oxaliplatin; Cetuximab; Radiation

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal 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; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Physical Phenomena

Study Officials

• Daniel G Haller, M.D.

  Abramson Cancer Center of University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• James M Metz, M.D.

  Abramson Cancer Center of University of Pennsylvania

  PRINCIPAL INVESTIGATOR

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: July 14, 2006
• First Posted: July 18, 2006
• Study Start: February 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 9, 2020

Record last verified: 2020-04