Pre-operative Chemo (CPT11, Cisplatin), Radiotherapy, Plus Surgery for Resectable Esophageal Cancer

NCT00160875 | Completed Phase 2 DMC

• 1 other identifier: 02-0484-C
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer of the esophagus is a very serious cancer. Studies have shown that using chemotherapy and radiation before surgery is the most promising treatment approach, with one quarter to one half of tumors shrinking by 50% or more in size after chemotherapy and radiation. In patients who have a very good response to this treatment, survival following esophagectomy has increased, although the amount of increase has varied quite a bit between the different studies. Older studies have used the drugs Cisplatin and 5-fluoruracil. Although this combination of drugs has been beneficial, we wish to use a newer combination of drugs which may be more effective for esophageal cancer. The chemotherapy drugs used in this study are Cisplatin and Irinotecan. We also want to find out what side effects these drugs cause when given with radiation, and how often these side effects occur.

Conditions

Esophageal Cancer

Keywords

esophageal; esophagus; irinotecan; CPT11; cisplatin

Outcome Measures

Primary Outcomes (1)

• pathological complete response

  1 day

Secondary Outcomes (9)

• acute and late toxicities

  5 yrs

• postoperative mortality

  1 month

• disease free survival

  5 yrs

• overall survival

  5 yrs

• Quality of life (FACT-E)

  5 yrs

Study Arms (1)

Cisplatin, Irinotecan

EXPERIMENTAL

Drug: Irinotecan hydrochloride trihydrate; Drug: Cisplatin

Interventions

Irinotecan hydrochloride trihydrate DRUG

Irinotecan (65mg/m2) weeks 1-2, 4-5, 7-8

Cisplatin, Irinotecan

Cisplatin DRUG

Cisplatin (30 mg/m2) weeks 1-2, 4-5, 7-8

Cisplatin, Irinotecan

Eligibility Criteria

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

You may qualify if:

• Histologically proven squamous or adenocarcinoma or the esophagus \>20 cm from the incisors, including GE junction tumors (unless of gastric origin). GE junction tumors are defined as tumors that have their center within 5 cm proximal and distal of the anatomical cardia
• Clinical T1 N1 M0, T2-3 N0-1 M0, T1-3 N0-1 M1a
• Performance status ECOG 0-2
• Medically fit for chemotherapy, radiation and esophagectomy
• Adequate bone marrow, hepatic and renal function as evidenced by the following:
• Hematology:
• Neutrophils \> 1.5 x 109/L Platelets \> 100 x 109/L
• Hepatic function:
• Total bilirubin \< 1.25x ULN AST (SGOT) and ALT (SGPT) \< 2.5 x ULN Alkaline phosphatase \<2.5 x ULN
• Renal function:
• Serum creatinine \< 160 umol/L or creatinine clearance \> 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows):
• weight (kg) x (140 - age) K x serum creatinine\*
• for serum creatinine in \*mol/L, K=0.814 in man, K=0.96 in woman
• No prior history of malignancy unless \> 5 years disease free, or adequately treated nonmelanotic skin cancer or in situ carcinoma of the cervix
• Tumor technically resectable (as defined in Section 5.4.3)

You may not qualify if:

• In situ or clinical T1N0M0
• Cervical esophageal tumors (within 20 cm of the incisors)
• Positive cytology of the pleura, peritoneum or pericardium
• Supraclavicular lymph node involvement
• Invasion of tracheobronchial tree proven by bronchoscopy including but not limited to tracheo-esophageal fistula
• Prior treatment for this malignancy except esophageal stenting
• Gilbert's disease
• Age \< 18
• Participation in another concurrent clinical study involving study drug(s) or treatment with study drug within thirty days prior to the treatment on this study. Concurrent treatment with other experimental drugs or anticancer therapy
• Known hypersensitivity to either of study drugs or to any of their excipients.
• Pregnant or lactating women. Men and women of reproductive potential (and women \< 12 months after menopause) may not participate unless they have agreed to use an effective contraceptive method while on study
• Known or suspected alcohol or drug abuse
• Other serious or concurrent illnesses that may interfere with subject compliance, adequate informed consent, determination of causality of adverse events and which in the judgement of the Investigator, would make the patient inappropriate for entry into the study
• Life expectancy \< 3 months
• Peripheral neuropathy \> Grade 2 (using CTC Version 2)

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Pfizer: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Cisplatin

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)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Darling E Gail, M.D., FRCSC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Knox J Jennifer, MD,MSc,FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Wong KS Rebecca, MSC, FRCSC

  University Health Network, Toronto

  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: September 8, 2005
• First Posted: September 12, 2005
• Study Start: April 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

CA (1)