Phase I Trial of Combined Modality Irinotecan, Cisplatin, and Concurrent Radiation Therapy for Patients With Locally Advanced Esophageal Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

Phase I Trial of Combined Modality Irinotecan, Cisplatin, and Concurrent Radiation Therapy for Patients With Locally Advanced Esophageal Cancer


OBJECTIVES:

- Determine the dose limiting toxicity of irinotecan when given weekly with cisplatin and
concurrent external beam multifield radiotherapy in patients with locally advanced
carcinoma of the esophagus or gastroesophageal junction.

- Determine the maximum tolerated dose and the recommended phase II dose of irinotecan in
this regimen in this patient population.

- Evaluate the complete response rate in these patients to one course of induction
chemotherapy followed by concurrent chemotherapy and radiotherapy.

OUTLINE: This is a dose escalation study of irinotecan.

Patients receive induction chemotherapy with cisplatin IV over 30 minutes followed by
irinotecan IV over 30 minutes on days 1, 8, 15, and 22. Following 2 weeks of rest, patients
begin chemoradiation. Patients receive cisplatin and irinotecan as above on days 1, 8, 22,
and 29 and radiotherapy once daily 5 days a week for 5-6 weeks.

Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose limiting toxicities.

Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus
or gastroesophageal junction

- T1, N1, M0 or T2-4, Nx, M0

- No supraclavicular or celiac lymph nodes

- Previously untreated, newly diagnosed tumors OR

- Prior resection without adjuvant therapy with local regional failure

- Positive microscopic margin on resection of all gross disease allowed provided
no metastatic disease

- No positive malignant cytology of the pleura, pericardium, or peritoneum

- No biopsy proven tumor invasion of the tracheobronchial tree or tracheoesophageal
fistula

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100% OR

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count greater than 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9.0 g/dL

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- No known Gilbert's disease

Renal:

- Creatinine no greater than 1.5 mg/dL

- No hypercalcemia

Cardiovascular:

- No New York Heart Association class III or IV heart disease

- No myocardial infarction within the past 6 months

- No uncontrolled hypertension

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other severe concurrent conditions (e.g., severe uncontrolled diabetes,
uncontrolled infections, or cerebral vascular disease)

- No other malignancy within the past 5 years except basal cell carcinoma of the skin
or carcinoma in situ of the cervix

- No history of seizure disorder currently receiving phenytoin, phenobarbital, or other
antiepileptic medication

- No other concurrent medical or psychiatric condition or disease that would preclude
study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for esophageal cancer including adjuvant chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy for esophageal cancer including adjuvant radiotherapy

- No prior mantle, chest, pelvic, or hemibody radiotherapy

Surgery:

- See Disease Characteristics

Other:

- No concurrent prochlorperazine on day of irinotecan administration

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David H. Ilson, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

99-081

NCT ID:

NCT00005638

Start Date:

October 1999

Completion Date:

April 2004

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • stage II gastric cancer
  • stage III gastric cancer
  • stage II esophageal cancer
  • stage III esophageal cancer
  • adenocarcinoma of the stomach
  • squamous cell carcinoma of the esophagus
  • adenocarcinoma of the esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804