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AzTrials

Esophageal CancerPhase 2NCT00217581

Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer

A Phase 2 study testing Bevacizumab, Docetaxel and Oxaliplatin in people with Esophageal Cancer and Gastric Cancer, run by Barbara Ann Karmanos Cancer Institute at 4 sites 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

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and kill them or carry tumor-killing substances to them. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Esophageal Cancer, Gastric Cancer
What is being tested?
Bevacizumab, Docetaxel and Oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
4 sitesUnited States
Study dates
Oct 2004to Jan 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed gastric or gastroesophageal junction adenocarcinoma
  • Locally advanced unresectable or metastatic disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10mm by spiral CT scan
  • Bone metastases, ascites, or pleural effusions are not considered measurable disease
  • Evaluable disease must be present outside previously irradiated field
  • No CNS or brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • SWOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 mg/dL
  • No evidence of bleeding diathesis or coagulopathy

Hepatic

  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ ULN
  • INR < 1.5

Renal

  • Creatinine < 2.0 mg/dL
  • Urine protein:creatinine ratio < 1.0

Cardiovascular

  • No history of deep venous thrombosis requiring anticoagulation
  • No active angina
  • No myocardial infarction within the past year
  • No cerebrovascular accident within the past year
  • No uncontrolled hypertension (systolic blood pressure [BP] > 170 mm Hg and/or diastolic BP > 100 mm Hg) despite medical management

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No peripheral neuropathy > grade 1
  • No history of allergy to any of the study drugs or drugs formulated with polysorbate 80
  • No known HIV infection
  • No active peptic ulcer disease
  • No serious non-healing wound, ulcer, or bone fracture
  • No unresolved bacterial infection requiring antibiotics
  • No other active malignancy within the past 3 years except for cancers that have been treated with a curative intent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy

Chemotherapy

  • No prior chemotherapy for gastric cancer unless disease relapsed > 6 months after completion of non-taxane adjuvant chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since radiotherapy

Surgery

  • At least 4 weeks since prior surgery or open biopsy (except indwelling venous catheter placement)
  • No concurrent surgery

Other

  • At least 4 weeks since prior and no concurrent participation in another experimental drug trial
  • No concurrent full-dose anticoagulation
  • No concurrent experimental drugs

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210-1240

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan, 48201

Other trials in United States

About this study

Official title: Phase II Trial of Bevacizumab, Docetaxel, and Oxaliplatin in Gastric and Gastroesophageal Junction Cancer

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with oxaliplatin and docetaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with oxaliplatin and docetaxel works in treating patients with locally advanced unresectable or metastatic stomach or gastroesophageal junction cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the time to progression in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma treated with bevacizumab, oxaliplatin, and docetaxel.

Secondary

  • Determine the response rate in patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.
  • Determine time to treatment failure and overall survival of patients treated with this regimen.
  • Determine the changes in general and disease-specific quality of life, in terms of response to treatment, in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 120 minutes, and docetaxel IV over 60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 18-23 months.

Keywords
recurrent gastric cancer, stage III gastric cancer, stage IV gastric cancer, recurrent esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, adenocarcinoma of the stomach
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.

  • BevacizumabBiological

    Also called Avastin

    Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.

  • DocetaxelDrug

    Also called Taxotere

    Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;

  • OxaliplatinDrug

    Also called Eloxatin

    Must be administered 3rd after Bevacizumab and Docetaxel. 75 mg/m(2), IV over 120 minutes, Day 1 of each cycle.

Study groups in NCT00217581
Study groupRoleWhat they receive
Docetaxel, Oxaliplatin & BevacizumabExperimentalMust be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.
Receives: Biological: Bevacizumab; Drug: Docetaxel; Drug: Oxaliplatin

What is being measured

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

  1. Time to Progression

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: After every 2 cycles (1 cycle =21 days) From study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months

Secondary outcomes (4)

  1. Response Rate by RECIST Criteria

    Percentage of Participants with response by RECIST criteria until progression

    Measured: After every 2 cycles (1 cycle =21 days)

  2. Toxicity Profile

    Toxicity profile of grade 3 and grade 4 events using the NCI-CTCAE Version 3.0 scale for toxicity grading.

    Measured: At 21 days following completion of study treatment

  3. Time to Treatment Failure

    Time to treatment failure using the Kaplan-Meier method

    Measured: Every 21 days From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  4. Overall Survival

    Overall survival using the Kaplan-Meier method

    Measured: Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years

Timeline

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

  1. First posted22 Sep 2005 (estimated)
  2. Study startOct 2004
  3. Primary completionNov 2012
  4. Study completionJan 2013

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
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00217581
Sponsor's protocol ID
CDR0000441641
Other IDs
P30CA022453, WSU-D-2840, UMCC-2005-052, AVENTIS-WSU-D-2840
Status last verified
Mar 2019
First submitted
20 Sep 2005
Last updated
26 Mar 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Docetaxel and Oxaliplatin in people with Esophageal Cancer and Gastric Cancer, run by Barbara Ann Karmanos Cancer Institute 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?

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 26 Mar 2019. 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?

Yes. Results are posted in the registry (first posted 7 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (time frame: After every 2 cycles (1 cycle =21 days) From study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months). 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 NCT00217581.

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 26 Mar 2019.

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