Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00020761
First received: July 11, 2001
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and paclitaxel in treating patients who have metastatic or recurrent cancer of the esophagus or stomach.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: irinotecan hydrochloride
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Irinotecan (Camptosar) And Paclitaxel (Taxol) In Patients With Adenocarcinoma Of The Upper Gastrointestinal Tract

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • To determine the antitumor activity of irinotecan and paclitaxel in patients with unresectable adenocarcinoma of the esophagus and gastric cardia. [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the toxicities of irinotecan and paclitaxel in this patient population. [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: April 2000
Study Completion Date: August 2005
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gastro Esophogeal cohort

Patients with adenocarcinoma of the esophagus, gastroesophageal (GE) junction and gastric cardia (GE cohort)

The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met.

Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks.

Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks.

Drug: irinotecan hydrochloride

The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met.

Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks.

Drug: paclitaxel

The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met.

Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks.

Experimental: Distal Stomach cohort

Patients with adenocarcinoma of the rest of the stomach (Distal Stomach cohort)

The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met.

Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks.

Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks.

Drug: irinotecan hydrochloride

The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met.

Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks.

Drug: paclitaxel

The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met.

Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks.


Detailed Description:

OBJECTIVES:

  • 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 toxicity.

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 study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 8.4.1.1, 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 trial.
  • 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 eligible.
  • Patients who have previously received a taxane or campthothecin
  • Patients who have received any investigational therapy within the previous 4 weeks.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020761

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Oregon
OHSU Cancer Institute
Portland, Oregon, United States, 97201-3098
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Joel R. Hecht, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Randolph Hecht, MD / Principal Investigator, UCLA
ClinicalTrials.gov Identifier: NCT00020761     History of Changes
Other Study ID Numbers: CDR0000068711, P30CA016042, UCLA-0001048, NCI-G01-1957
Study First Received: July 11, 2001
Last Updated: July 27, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
stage IV gastric cancer
recurrent gastric cancer
stage IV esophageal cancer
recurrent esophageal cancer
adenocarcinoma of the stomach
adenocarcinoma of the esophagus

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Irinotecan
Camptothecin
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014