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Esophageal CancerPhase 2NCT00201747

Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Esophageal and Stomach Cancer

A Phase 2 study testing CPT-11 and Mitomycin C in people with Esophageal Cancer and Esophagus Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine the most efficacious of two combination regimens of sequential CPT-11 and MMC in patients with advanced and previously untreated esophageal and GE junction adenocarcinomas. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CPT-11 and Mitomycin C
Type of treatment
Injection or infusion
How many people
80 participants
Where
1 siteUnited States
Study dates
Sep 2001to Feb 2010
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

  • Must have pathologically confirmed \& measurable advanced esophageal or Gastroesophageal junction adenocarcinoma
  • No prior chemotherapy
  • Prior radiation allowed if <=20% of bone marrow was irradiated
  • Target lesions must not be in radiation field.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Phase II Randomized Trial of Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Esophageal and Stomach Cancer

To determine the most efficacious of two combination regimens of sequential CPT-11 and MMC in patients with advanced and previously untreated esophageal and GE junction adenocarcinomas.

Read the detailed description

Rationale: Previous studies suggest that both irinotecan and Mytomycin C when administered alone have some efficacy against stomach cancer. Based on laboratory testing, researchers hypothesized that Mytomycin C may enhance the efficacy of irinotecan through an enzyme called Topoisomerase I. In addition, because Mytomycin C has severe side effects, combining these chemotherapy agents together may allow for lower dosages resulting in greater efficacy and reduced side effects. A recent study indicates that the combination of these drugs has promising anti-tumor activity against esophageal and stomach cancers. The current study builds on previous research to explore the most effective schedule for administering these drugs together.

Purpose: This study is evaluating the combination of irinotecan and Mytomycin C on two different treatment schedules in patients with advanced esophageal and stomach cancers. Characteristics of different genes will also be measured, along with genetic and molecular changes by comparing test results from the beginning and end of the study.

Treatment: Patients in this study will receive irinotecan and Mytomycin C in one of two treatment schedules. Both drugs will be administered in patients through an intravenous infusion. A computer will randomly assign patients to a treatment group. Group one will receive Mytomycin C on day 1 and irinotecan on days 2 and 9. Group two will receive Mytomycin C on days 1 and 8 and irinotecan on days 2 and 9. After day 9, patients in both groups will not be given any study drugs for almost three weeks to complete a four week cycle. Several tests and exams will be given throughout the study to closely monitor patients. Patients will continue receiving the study drugs until they experience disease growth or unacceptable side effects.

Being tested
CPT-11, Mitomycin C
Keywords
Advanced
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPT-11Drug

    CPT-11 will be administered intravenously on days 2 and 9 (24 hours after MMC, when the MMC is required) Two weeks of rest (beginning days 15 and 22) (drug free) will complete the cycle, with therapy planned to be resumed on day 29.

  • Mitomycin CDrug

    MMC will be administered intravenously on day 1 (Arm A) and days 1 and 8 (Arm B)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Most efficacious of two combination regimens of sequential CPT-11 and MMC in patients with advanced and previously untreated esophageal and GE junction adenocarcinomas

    Measured: 2001-2010

Secondary outcomes (3)

  1. Evaluate gene expression profile of NQ01, and Topo I genes in peripheral blood mononuclear cells and tumor tissue during therapy with MMC and CPT-11

    Measured: 2001-2010

  2. Evaluate the frequency of NQ01 gene mutations in patients with esophageal and GE junction adenocarcinomas and its association to prognosis and antitumor activity.

    Measured: 2001-2010

  3. Evaluate if pre- and/or post-treatment Topo I-, CE and NQ01-gene expression in fresh tumor specimens and adjacent tissue, are associated with antitumor efficacy or toxicity.

    Measured: 2001-2010

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startSep 2001
  3. Primary completionOct 2006
  4. Study completionFeb 2010

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00201747
Sponsor's protocol ID
OSU-0151
Status last verified
Dec 2017
First submitted
12 Sep 2005
Last updated
6 Dec 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Lustberg MB, Bekaii-Saab T, Young D, Otterson G, Burak W, Abbas A, McCracken-Bussa B, Lustberg ME, Villalona-Calero MA. Phase II randomized study of two regimens of sequentially administered mitomycin C and irinotecan in patients with unresectable esophageal and gastroesophageal adenocarcinoma. J Thorac Oncol. 2010 May;5(5):713-8. doi: 10.1097/JTO.0b013e3181d7776d.

    PubMed 20354452

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CPT-11 and Mitomycin C in people with Esophageal Cancer and Esophagus Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site 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 4 inclusion and 0 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 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Most efficacious of two combination regimens of sequential CPT-11 and MMC in patients with advanced and previously untreated esophageal and GE junction adenocarcinomas (time frame: 2001-2010). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00201747, which also lists 1 linked publication.

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 6 Dec 2017.

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