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Adenocarcinoma of the Gastroesophageal JunctionPhase 2NCT00084604

Irinotecan, Cisplatin, and Bevacizumab in Treating Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

A Phase 2 study testing irinotecan hydrochloride, bevacizumab and cisplatin in people with Adenocarcinoma of the Gastroesophageal Junction and Diffuse Adenocarcinoma of the Stomach, run by National Cancer Institute (NCI) 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

This phase II trial is studying how well giving irinotecan and cisplatin together with bevacizumab works in treating patients with unresectable or metastatic gastric (stomach) or gastroesophageal junction adenocarcinoma (cancer). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
irinotecan hydrochloride, bevacizumab and cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteUnited States
Study dates
Apr 2004to Oct 2007
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

  • Histologically or cytologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma
  • Metastatic or unresectable disease
  • Siewert's classification I, II, or III
  • No ulcerated, non-healing tumors or tumors that have developed a malignant fistula
  • No esophageal tumors
  • No known or active brain metastases
Show all 69Show fewer
  • Performance status - Karnofsky 60-100%
  • Performance status - ECOG 0-2
  • Neutrophil count >= 1,500/mm^3
  • Platelet count >= 75,000/mm^3
  • No bleeding diathesis or coagulopathy
  • Bilirubin =< 1.5 mg/dL
  • AST and ALT =< 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
  • PT (INR) =< 1.5
  • PTT =< 3 seconds above ULN
  • Creatinine =< 1.5 mg/dL
  • Proteinuria < 1+
  • Protein < 500 mg/24-hour urine collection
  • No acute ischemia or significant conduction abnormality by EKG
  • No clinically significant cardiovascular disease
  • No uncontrolled hypertension (blood pressure > 160/90 mm Hg on medication)
  • No myocardial infarction within the past 6 months
  • No unstable angina within the past 6 months
  • No transient ischemic attack within the past 6 months
  • No cerebrovascular accident within the past 6 months
  • No other arterial thromboembolic event within the past 6 months
  • No New York Heart Association class II-IV congestive heart failure
  • No serious cardiac dysrhythmia requiring medication
  • No peripheral vascular disease (grade II or greater)
  • No history of stroke
  • No CNS disease within the past 5 years (e.g., uncontrolled seizures)
  • No other concurrent uncontrolled illness
  • No ongoing or active infection requiring parental antibiotics on Day 0 of study
  • No serious, non-healing wound
  • No serious wound healing by secondary intention
  • No ulcer
  • No bone fracture
  • No psychiatric illness or social situation that would preclude study compliance
  • No significant traumatic injury within the past 28 days
  • No other neoplastic disease within the past 3 years except basal cell skin cancer, carcinoma in situ of the cervix, or nonmetastatic prostate cancer
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No other medical condition that would preclude study participation
  • Not pregnant or nursing
  • No nursing during and for 4 months after study participation
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 months after study participation
  • More than 8 weeks since prior immunotherapy and recovered
  • No other concurrent biologic or immunologic agents
  • No other concurrent bevacizumab
  • No prior chemotherapy for metastatic disease
  • No prior cisplatin or irinotecan
  • Prior neoadjuvant and/or adjuvant chemotherapy or chemoradiotherapy allowed
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No other concurrent chemotherapy
  • More than 3 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy
  • More than 28 days since prior major surgical procedure or open biopsy
  • More than 7 days since prior fine needle aspirations or core biopsies
  • No concurrent major surgery
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • No concurrent chronic daily aspirin (> 325 mg/day)
  • No concurrent nonsteroidal anti-inflammatory medications that would inhibit platelet function at doses used to treat chronic inflammatory diseases
  • Full-dose anticoagulants allowed, provided the following criteria are met:
  • INR in range (i.e., 2-3) while on a stable dose of warfarin or low molecular weight heparin
  • No active bleeding or pathologic condition that would confer a high risk of bleeding (e.g., tumor involving major blood vessels or known varices)
  • No concurrent thrombolytic agents
  • No concurrent vitamins, antioxidants, herbal preparations, or supplements
  • Single tablet multivitamin allowed

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Multicenter, Open-Label, Phase II Study of Irinotecan, Cisplatin, and Bevacizumab in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

This phase II trial is studying how well giving irinotecan and cisplatin together with bevacizumab works in treating patients with unresectable or metastatic gastric (stomach) or gastroesophageal junction adenocarcinoma (cancer). Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving chemotherapy together with a monoclonal antibody may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the efficacy of irinotecan, cisplatin, and bevacizumab, in terms of time to progression, in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

SECONDARY OBJECTIVES:

  1. Determine other measures of efficacy, including response rate and median and 1-year survival, in patients treated with this regimen.

II. Determine the toxicity of this regimen in these patients. III. Correlate CT perfusion imaging results with the efficacy of this regimen, in terms of time to progression, objective response, and survival, in these patients.

IV. Determine the feasibility of serial serum proteomic assays in predicting response to therapy, in terms of time to progression, objective response, and survival, in patients treated with this regimen.

  1. To bank paraffin stored tumor biopsy material for future planned immunohistochemistry studies to correlate with sensitivity to bevacizumab based combination chemotherapy.

OUTLINE: This is an open-label, non-randomized, multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year.

Being tested
irinotecan hydrochloride, bevacizumab, cisplatin, computed tomography, laboratory biomarker analysis
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • irinotecan hydrochlorideDrug

    Also called Campto, Camptosar, CPT-11, irinotecan

    Given IV

  • bevacizumabBiological

    Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

    Given IV

  • cisplatinDrug

    Also called CACP, CDDP, CPDD, DDP

    Given IV

  • computed tomographyProcedure or surgery

    Also called tomography, computed

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00084604
Study groupRoleWhat they receive
Treatment (bevacizumab, cisplatin, irinotecan)ExperimentalPatients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: irinotecan hydrochloride; Biological: bevacizumab; Drug: cisplatin; Procedure: computed tomography; Other: laboratory biomarker analysis

What is being measured

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

  1. Time to progression, evaluated using RECIST

    Kaplan-Meier estimates will be used.

    Measured: Up to 1 year

Secondary outcomes (5)

  1. Overall response rate, evaluated using RECIST

    95% exact binomial confidence intervals will be used to describe the distribution.

    Measured: Up to 1 year

  2. Complete response rate, evaluated using RECIST

    95% exact binomial confidence intervals will be used to describe the distribution.

    Measured: Up to 1 year

  3. Duration of response, evaluated using RECIST

    Measured: From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 1 year

  4. Survival

    Kaplan-Meier estimates will be used.

    Measured: Up to 1 year

  5. Incidence of toxicity, evaluated using CTCAE version 3.0

    Measured: Up to 1 year

Timeline

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

  1. First posted11 Jun 2004 (estimated)
  2. Study startApr 2004
  3. Primary completionOct 2007

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
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00084604
Sponsor's protocol ID
NCI-2012-01450
Other IDs
04-021, NCI-6447, MSKCC-04021, CDR0000365463, N01CM17105, U01CA099168
Status last verified
Jun 2013
First submitted
10 Jun 2004
Last updated
4 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing irinotecan hydrochloride, bevacizumab and cisplatin in people with Adenocarcinoma of the Gastroesophageal Junction and Diffuse Adenocarcinoma of the Stomach, run by National Cancer Institute (NCI) 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 69 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 4 Jun 2013. 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?

Time to progression, evaluated using RECIST (time frame: Up to 1 year). 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 NCT00084604.

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 4 Jun 2013.

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