Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach
A Phase II Study Of Irinotecan (Camptosar) And Paclitaxel (Taxol) In Patients With Adenocarcinoma Of The Upper Gastrointestinal Tract
3 other identifiers
interventional
51
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2000
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2000
CompletedFirst Submitted
Initial submission to the registry
July 11, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedAugust 3, 2020
July 1, 2012
2.7 years
July 11, 2001
July 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the antitumor activity of irinotecan and paclitaxel in patients with unresectable adenocarcinoma of the esophagus and gastric cardia.
5 months
Secondary Outcomes (1)
To evaluate the toxicities of irinotecan and paclitaxel in this patient population.
5 months
Study Arms (2)
Gastro Esophogeal cohort
EXPERIMENTALPatients 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.
Distal Stomach cohort
EXPERIMENTALPatients 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013, United States
OHSU Cancer Institute
Portland, Oregon, 97201-3098, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Joel R. Hecht, MD
Jonsson Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 11, 2001
First Posted
January 27, 2003
Study Start
April 1, 2000
Primary Completion
December 1, 2002
Study Completion
August 1, 2005
Last Updated
August 3, 2020
Record last verified: 2012-07