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A Phase II Study Of Irinotecan (Camptosar) And Paclitaxel (Taxol) In Patients With Adenocarcinoma Of The Upper Gastrointestinal Tract

Phase 2
18 Years
Not Enrolling
Esophageal Cancer, Gastric Cancer

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Trial Information

A Phase II Study Of Irinotecan (Camptosar) And Paclitaxel (Taxol) In Patients With Adenocarcinoma Of The Upper Gastrointestinal Tract


- Determine the antitumor activity of irinotecan and paclitaxel in patients with
metastatic or recurrent adenocarcinoma of the esophagus or stomach.

- Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis
(adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia vs
adenocarcinoma of the rest of the stomach).

Patients receive irinotecan IV over 90 minutes followed by paclitaxel IV over 3 hours on day
1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable

Patients are followed at 30 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 26-54 patients (13-27 per stratum) will be accrued for this

Inclusion Criteria

Inclusion Criteria

- Patients with histologic proof of adenocarcinoma of the esophagus (including GE
junction) or adenocarcinoma of the stomach will be eligible.

- Location of the tumor for assignment to study will be determined by prior endoscopy
or barium contrast study.

- Patients must have either metastatic or recurrent cancer.

- Patients must have bidimensionally measurable disease, as defined in Section,
page 16. Mediastinal or hilar lymph nodes assessed by CT or MRI scans must be at
least 2 cm in the largest dimension to be considered measurable.

- Prior limited radiation therapy is permitted. Prior radiotherapy must not have
included major bone marrow containing areas (pelvis, lumbar spine), or contained the
single evaluable lesion in a radiation field. A recovery period of at least 4 weeks
after completion of radiotherapy is required prior to study treatment.

- Patients must have an anticipated life expectancy of at least 12 weeks.

- Patients must have a performance status of 0 or 1 on the ECOG performance scale.

- Patients must be > 18 years old.

- Patients must give written informed consent prior to enrollment.

- Patients should have adequate organ function defined as follows: Absolute
granulocytes > 1,500/mm3 and platelets > 100,000/mm3; serum bilirubin < 1.5 mg/dL and
SGOT < 3X upper limit of institutional norm; and serum creatinine < 1.5 mg/dL.

- Patients must have recovered from recent surgery. One week must have elapsed from
the time of a minor surgery and 3 weeks from major surgery.

Exclusion Criteria

- Patients who have received more than one prior chemotherapy regimen or immunotherapy
for metastatic disease. Prior 5-FU alone as an adjuvant therapy or radiosensitizer
is not counted. Patients must have an interval of 4 weeks from prior chemotherapy or
immunotherapy with full recovery.

- Patients receiving concurrent chemotherapy, immunotherapy, or radiotherapy.

- Patients who are potentially curable with a chemotherapy, radiotherapy, surgery, or
any combination of the above.

- Patients with known brain metastases.

- Patients with a history of seizures or are receiving phenytoin, phenobarbital, or
other antiepileptic prophylaxis.

- Pregnant or lactating women. All women of childbearing potential must have a
negative pregnancy test prior to entry into the study. All patients of procreative
potential must be advised of the importance of avoiding pregnancy and using
appropriate methods of contraception while participating in this investigational

- Patients with serious intercurrent infections, or any other concurrent disease which,
in the investigator's judgment, would make the patient inappropriate for entry into
this study.

- Patients with psychiatric disorders rendering them incapable of complying with the
requirements of the protocol.

- Patients with osseous metastasis as only site of disease.

- Patients with any concurrent active malignancy other than non-melanoma skin cancers
or carcinoma-in-situ of the cervix. Patients with previous malignancies but without
evidence of disease for > 5 years will be allowed to enter the trial.

- Patients with known Gilbert's syndrome.

- Patients who have a significant clinical neuropathy of greater than grade 2.

- Patients with unstable angina, a history of myocardial infarction within the previous
6 months, or current clinical evidence of congestive heart failure. Patients taking
medication for congestive heart failure and showing no clinical signs or symptoms are

- Patients who have previously received a taxane or campthothecin

- Patients who have received any investigational therapy within the previous 4 weeks.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the antitumor activity of irinotecan and paclitaxel in patients with unresectable adenocarcinoma of the esophagus and gastric cardia.

Outcome Time Frame:

5 months

Safety Issue:


Principal Investigator

Joel R. Hecht, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 2000

Completion Date:

August 2005

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • stage IV esophageal cancer
  • recurrent esophageal cancer
  • adenocarcinoma of the stomach
  • adenocarcinoma of the esophagus
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
OHSU Cancer Institute Portland, Oregon  97239