Esophageal CancerPhase 2NCT00020761
Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach
A Phase 2 study testing irinotecan hydrochloride and paclitaxel in people with Esophageal Cancer and Gastric Cancer, run by Jonsson Comprehensive Cancer Center at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer
- What is being tested?
- irinotecan hydrochloride and paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2000to Aug 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
OHSU Cancer Institute
Portland, Oregon, 97201-3098
About this study
Official title: A Phase II Study Of Irinotecan (Camptosar) And Paclitaxel (Taxol) In Patients With Adenocarcinoma Of The Upper Gastrointestinal Tract
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.
Read the 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.
- Conditions
- Esophageal Cancer, Gastric Cancer
- Being tested
- irinotecan hydrochloride, paclitaxel
- Keywords
- stage IV gastric cancer, recurrent gastric cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
paclitaxelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Gastro Esophogeal cohort | Experimental | 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. Receives: Drug: irinotecan hydrochloride; Drug: paclitaxel |
| Distal Stomach cohort | Experimental | 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. Receives: Drug: irinotecan hydrochloride; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the antitumor activity of irinotecan and paclitaxel in patients with unresectable adenocarcinoma of the esophagus and gastric cardia.
Measured: 5 months
Secondary outcomes (1)
To evaluate the toxicities of irinotecan and paclitaxel in this patient population.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 2000
- Primary completionDec 2002
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Joel R. Hecht, MD, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00020761
- Sponsor's protocol ID
- CDR0000068711
- Other IDs
- UCLA-0001048, NCI-G01-1957
- Status last verified
- Jul 2012
- First submitted
- 11 Jul 2001
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Irinotecan (Camptosar) And Paclitaxel (Taxol) In Patients With Adenocarcinoma Of The Upper Gastrointestinal Tract
- ClinicalTrials.gov ID
- NCT00020761
- Acronym / sponsor ID
- CDR0000068711
- Conditions
- Esophageal Cancer, Gastric Cancer
- Keywords
- stage IV gastric cancer, recurrent gastric cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Apr 2000
- Primary completion
- Dec 2002 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastro Esophogeal cohort | Experimental | Drug: irinotecan hydrochloride, Drug: paclitaxelPatients 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 | Experimental | Drug: irinotecan hydrochloride, Drug: paclitaxelPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| irinotecan hydrochlorideThe 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 | Distal Stomach cohort, Gastro Esophogeal cohort |
| paclitaxelThe 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. | Drug | Distal Stomach cohort, Gastro Esophogeal cohort |
Primary outcome
To determine the antitumor activity of irinotecan and paclitaxel in patients with unresectable adenocarcinoma of the esophagus and gastric cardia.
Time frame: 5 months
1 secondary outcome
To evaluate the toxicities of irinotecan and paclitaxel in this patient population.
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel R. Hecht, MD study chair
Jonsson Comprehensive Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing irinotecan hydrochloride and paclitaxel in people with Esophageal Cancer and Gastric Cancer, run by Jonsson Comprehensive Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the antitumor activity of irinotecan and paclitaxel in patients with unresectable adenocarcinoma of the esophagus and gastric cardia. (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.