Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.

NCT00590031 | Completed Phase 2 Results

• 2 other identifiers: 02-045IND 65889
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4 and 5. Patients will then receive weekly irinotecan, cisplatin, and concurrent radiotherapy with chemotherapy given once weekly, weeks 8,9,11 and 12 during the six weeks of radiotherapy. Patients will be referred for surgery 4-8 weeks after completion of chemoradiotherapy.

Conditions

Esophageal Carcinoma

Keywords

Esophageal Carcinoma; Cisplatin; Irinotecan; Radiation Therapy; 02-045

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response

  Pathological information will be available for all patients who receive surgery. If a patient is deemed unresectable based on clinical and radiological examination after the therapy, that patient will be counted as non-responder. The best overall response is the best response recorded from the start of treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The subject's best response assignment will depend on the achievement of both measurement and confirmation criteria. We will also estimate the pathological complete response rates separately for each of these tumor types. Survival and disease-free survival will be estimated using Kaplan-Meier method. With an accrual rate of 3 patients a month, we expect the study to be completed in 18 months.

  2 years

Secondary Outcomes (1)

• Evaluate Toxicity and Tolerability Including Surgical Morbidity and Mortality

  2 years

Study Arms (1)

1

EXPERIMENTAL

External Beam Radiation Therapy, Cisplatin, Irinotecan

Drug: Cisplatin; Drug: Irinotecan; Radiation: External Beam Radiation Therapy

Interventions

Cisplatin DRUG

pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12

1

Irinotecan DRUG

Irinotecan will be given 65 mg/m2

1

External Beam Radiation Therapy RADIATION

will be delivered with multiple (\>2) field techniques using mega-voltage radiation therapy. pts will receive 50.4 Gy and will be treated over a 6 week period.

1

Eligibility Criteria

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

You may qualify if:

• Patients must be able to sign the informed consent document.

You may not qualify if:

• Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound, or CT scanning.
• Cervical esophageal tumors,
• Gastric cancers with minor involvement of the gastroesophageal junction or distal esophagus.
• Prior chemotherapy or radiation.
• Patients with evidence of metastatic disease are not eligible. This includes:
• Positive malignant cytology of the pleura, pericardium or peritoneum.
• Radiographic evidence of distant organ involvement including lung, liver, bone, or brain.
• Patients with involvement of non-regional lymph nodes including supraclavicular or celiac lymph node metastases.
• Biopsy proven tumor invasion of the tracheobronchial tree or presence of tracheoesophageal fistula. Recurrent laryngeal nerve or phrenic nerve paralysis,
• New York Heart Association Class III or 1V heart disease. Angina or myocardial infarction within the last 6 months, history of significant ventricular arrhythmia requiring medication with antiarrhythmics, or a history of a clinically significant conduction system abnormality.
• Severe co-morbid conditions including severe uncontrolled diabetes, uncontrolled hypertension, cerebral vascular disease, uncontrolled infection, or nonmalignant illness whose control may be jeopardized by the complications of this study treatment.
• Pregnant or lactating women are ineligible as the effect of the drugs used in this study on a fetus or newborn child are unknown. Premenopausal fertile females require a negative pregnancy test prior to study entry. Treatment may not begin until the results of the pregnancy tests are ascertained. Both sexes must use contraception while on this study.
• History of prior malignancy (other than basal cell/squamous carcinoma of the skin, in-situ cervical carcinoma, or superficial transitional cell bladder carcinoma) diagnosed and/or treated within three years of entrance into this study.
• Patients with known Gilbert's Disease.
• Clinically significant hearing loss.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Cisplatin; Irinotecan

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; Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. David Ilson, Attending
• Organization: Memorial Sloan Kettering Cancer Center

ilsond@mskcc.org

+1646-888-4183

Study Officials

• David Ilson, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: December 26, 2007
• First Posted: January 10, 2008
• Study Start: November 1, 2002
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 25, 2016
• Results First Posted: January 25, 2016

Record last verified: 2015-12

Locations

US (1)