Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma

NCT00815308 | Completed Phase 2 Results DMC

• 1 other identifier: SDRTC-0901
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the treatment of locally advanced esophageal squamous cell carcinoma (ESCC)with cetuximab in combination with paclitaxel, cisplatin and radiation improve clinical outcomes.

Conditions

Esophageal Cancer

Keywords

Therapeutic; Drug Therapy, combination; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Overall Response Rate (RR)

  The overall response rate was defined as the numbers of patients with a complete response (CR) or partial response (PR). CR was defined as no target lesion at follow-up computed tomography scan and barium swallow examination 3-6 weeks after completion of chemo-radiation. PR was defined at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  1 to 3 month after therapy

Secondary Outcomes (5)

• Number of Participants With Toxicity

  Every week during treatment and 1 month after therapy

• Participants With Overall Survival (OS) at 1 Year

  1 year from the date of diagnosis

• Participants With Overall Survival (OS) at 3 Year

  3 year from the date of diagnosis

• Participants With Progression Free Survival (PFS)

  Recurrence or metastasis from the date of diagnosis

• Number of Participants With K-ras Gene Mutation

  07/29/2010-09/30/2010

Study Arms (1)

cetuximab, concurrent chemo-radiotherapy

EXPERIMENTAL

Cetuximab, injection, loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m\^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m\^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8

Drug: cetuximab (Erbitux); Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiation

Interventions

cetuximab (Erbitux) DRUG

Cetuximab,injection,loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8)

Also known as: erbitux

cetuximab, concurrent chemo-radiotherapy

Paclitaxel DRUG

Paclitaxel,injection,loading dose 45 mg/m\^2,(Day1 in every week for Weeks 2-8)

cetuximab, concurrent chemo-radiotherapy

Cisplatin DRUG

Cisplatin,injection,loading dose 20 mg/m\^2,(Day1 in every week for Weeks 2-8)

cetuximab, concurrent chemo-radiotherapy

Radiation RADIATION

Radiation, External beam therapy, total 59.4 Gy , 33 fractions, 1.8 Gy per fraction.(Day 1-Day 5 in every week 2-week 8).

Also known as: Conformal Radiotherapy, Intensity Modulated Radiotherapy

cetuximab, concurrent chemo-radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatients or outpatients, ≥ 18 years of age
• Histologically confirmed primary (non-recurrent) ESCC fulfilling one of the following criteria (AJCC Staging System)
• cervical esophageal carcinoma, stage Ⅱ-Ⅲ
• upper thoracic esophageal carcinoma, stage Ⅱ-Ⅲ, or mid-thoracic esophageal carcinoma, stage Ⅱ-Ⅲ,which is medically unfit for surgery, surgery been refused and patient medically able to tolerate chemo-radiation.
• Evidence of unidimensional measurable disease as per Response Evaluation Criteria in Solid Tumours (RECIST).
• ECOG Performance status of 0-1
• Effective contraception for both male and female patients if the risk of conception exists
• Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm\^3, platelet count ≥ 100,000 /mm\^3, hemoglobin ≥ 9 g/dl
• Adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60 ml/min
• Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT \& ALST ≤ 1.5 x ULN
• Tumor tissue available for KRAS biomarker test
• Signed written informed consent prior to study entry

You may not qualify if:

• Previous chest radiotherapy, systemic chemotherapy, and major esophageal surgery
• Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol
• Multiple primary carcinomas of the esophagus
• Pregnancy (confirmed by serum or urine β-HCG) or lactation period;
• Uncontrolled diabetes, hypertension, and severe cardiac or pulmonary disease
• Unable to comprehend the study requirements or who are not likely to comply with the study parameters;
• Distant metastasis
• Second malignancy, except for curable non-melanoma skin cancer, cervical cancer in situ, or malignant disease, free for ≥ 5 years
• Known grade 3 or 4 allergic reaction to any of the study treatment

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead
• Chinese Academy of Medical Sciences: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Hebei Fourth Hospital: collaborator
• Jiangsu Cancer Institute & Hospital: collaborator
• RenJi Hospital: collaborator
• The Affiliated Cancer Hospital of Zhengzhou University: collaborator
• West China Hospital: collaborator

Study Sites (1)

Department of Radiation Oncology, Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

Location

Related Publications (8)

• Urba SG, Orringer MB, Turrisi A, Iannettoni M, Forastiere A, Strawderman M. Randomized trial of preoperative chemoradiation versus surgery alone in patients with locoregional esophageal carcinoma. J Clin Oncol. 2001 Jan 15;19(2):305-13. doi: 10.1200/JCO.2001.19.2.305.

  PMID: 11208820 RESULT

• Kelsen DP, Ginsberg R, Pajak TF, Sheahan DG, Gunderson L, Mortimer J, Estes N, Haller DG, Ajani J, Kocha W, Minsky BD, Roth JA. Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer. N Engl J Med. 1998 Dec 31;339(27):1979-84. doi: 10.1056/NEJM199812313392704.

  PMID: 9869669 RESULT

• Bosset JF, Gignoux M, Triboulet JP, Tiret E, Mantion G, Elias D, Lozach P, Ollier JC, Pavy JJ, Mercier M, Sahmoud T. Chemoradiotherapy followed by surgery compared with surgery alone in squamous-cell cancer of the esophagus. N Engl J Med. 1997 Jul 17;337(3):161-7. doi: 10.1056/NEJM199707173370304.

  PMID: 9219702 RESULT

• Walsh TN, Noonan N, Hollywood D, Kelly A, Keeling N, Hennessy TP. A comparison of multimodal therapy and surgery for esophageal adenocarcinoma. N Engl J Med. 1996 Aug 15;335(7):462-7. doi: 10.1056/NEJM199608153350702.

  PMID: 8672151 RESULT

• Herskovic A, Martz K, al-Sarraf M, Leichman L, Brindle J, Vaitkevicius V, Cooper J, Byhardt R, Davis L, Emami B. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med. 1992 Jun 11;326(24):1593-8. doi: 10.1056/NEJM199206113262403.

  PMID: 1584260 RESULT

• Raben D, Helfrich B, Bunn PA Jr. Targeted therapies for non-small-cell lung cancer: biology, rationale, and preclinical results from a radiation oncology perspective. Int J Radiat Oncol Biol Phys. 2004;59(2 Suppl):27-38. doi: 10.1016/j.ijrobp.2004.01.054.

  PMID: 15142632 RESULT

• Langer CJ. Emerging role of epidermal growth factor receptor inhibition in therapy for advanced malignancy: focus on NSCLC. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):991-1002. doi: 10.1016/j.ijrobp.2003.09.099.

  PMID: 14967461 RESULT

• Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. doi: 10.1056/NEJMoa053422.

  PMID: 16467544 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Cetuximab; Paclitaxel; Cisplatin; Radiation; Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Physical Phenomena; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Jinming Yu
• Organization: Shandong Cancer Hospital and Institute

jn7984729@public.jn.sd.cn

86-531-87984729

Study Officials

• Jin Ming Yu, PH.D, M.D

  Shandong Cancer Hospital and Institute

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 29, 2008
• First Posted: December 30, 2008
• Study Start: January 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: February 8, 2011
• Results First Posted: February 3, 2011

Record last verified: 2009-07

Locations

CN (1)