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Stage IA Pancreatic CancerPhase 2NCT00305877

Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery

A Phase 2 study testing cetuximab, gemcitabine hydrochloride and capecitabine in people with Stage IA Pancreatic Cancer and Stage IB Pancreatic Cancer, 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 randomized phase II trial is studying bevacizumab to see how well it works compared to cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating patients with pancreatic cancer that has been completely removed by surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cetuximab, gemcitabine hydrochloride and capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
137 participants
Where
1 siteUnited States
Study dates
Feb 2006to Feb 2012
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma
  • Patients must have had all gross disease resected (R0 or R1 resection)
  • Patients undergoing an R2 resection are not eligible
  • Patients must have had no prior chemotherapy or radiation therapy for pancreatic cancer and must have had no prior EGFR/VEGF inhibition
  • Patient must have ECOG performance status of 0-2
  • Leukocytes >= 3,000/μL
Show all 28Show fewer
  • ANC >= 1,500/μL
  • Platelets >= 100,000/μL
  • Total bilirubin Within normal institutional limits
  • AST (SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal
  • Creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal
  • Patients must be > 4 weeks and =< 8 weeks post-surgery at time of study registration (may be up to 10 weeks post-surgery prior to start of study therapy)
  • Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception prior to study entry
  • Women must not be pregnant or breast-feeding; all agents used in this study as well as radiation therapy to the abdomen have the potential for teratogenic or abortifacient effects; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
  • Patients must not be receiving any other investigational agents
  • Patients with known metastases are not eligible
  • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab, bevacizumab or other agents used in the study are not eligible
  • Patients with wounds that have not fully healed are not eligible
  • Patients must not have cardiac arrhythmia
  • Patients must have no known HIV infection
  • Patients must not have any of the following: acinar cell carcinoma, neuroendocrine carcinoma, cystadenocarcinoma, carcinosarcoma
  • Patients with psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude them from meeting the study requirements are not eligible
  • Patients requiring full dose anticoagulation are not eligible
  • Patients with a history of transient ischemic attack (TIA) or cerebrovascular accident (CVA) are not eligible
  • Patients with a history of the following within twelve months of study entry are not eligible:
  • Arterial thrombembolic events
  • Unstable angina
  • Myocardial infarction

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Eastern Cooperative Oncology Group

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or Cetuximab (NSC 714692) in Combination With Gemcitabine and in Combination With Chemoradiation (Capecitabine and Radiation) in Patients With Completely-Resected Pancreatic Carcinoma

This randomized phase II trial is studying bevacizumab to see how well it works compared to cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating patients with pancreatic cancer that has been completely removed by surgery. Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help 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. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab or cetuximab together with gemcitabine, capecitabine, and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether bevacizumab is more effective than cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating pancreatic cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To describe the toxicity profile of cetuximab and bevacizumab when combined with gemcitabine, before and after capecitabine plus radiation and during capecitabine plus radiation in patients with completely-resected pancreatic carcinoma in the adjuvant setting.

II. To assess the safety profile of either cetuximab or bevacizumab plus gemcitabine in patients with resected pancreatic cancer.

III. To obtain tissue specimens from resections of patients enrolled on study for correlative studies and further evaluations.

SECONDARY OBJECTIVES:

  1. To evaluate disease-free and overall survival for patients receiving either cetuximab or bevacizumab in combination with gemcitabine before and after capecitabine plus radiation.

II. To assess the safety profile for patients receiving either capecitabine plus cetuximab plus radiation, or capecitabine plus bevacizumab plus radiation.

III. To correlate changes in serum amphiregulin and TGF alpha to survival, DFS and rash for patients receiving cetuximab.

IV. To determine the 2-year survival rate for patients receiving either cetuximab plus gemcitabine before and after capecitabine plus cetuximab plus radiation, or bevacizumab plus gemcitabine before and after capecitabine plus bevacizumab plus radiation.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to degree of prior resection of the pancreatic tumor (R0 vs R1). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).

Arm II: Patients receive bevacizumab IV over 60-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in arm I.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.

Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • cetuximabBiological

    Also called C225, C225 monoclonal antibody, IMC-C225, MOAB C225

    Given IV

  • gemcitabine hydrochlorideDrug

    Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

    Given IV

  • capecitabineDrug

    Also called CAPE, Ro 09-1978/000, Xeloda

    Given orally

  • radiation therapyRadiation

    Also called irradiation, radiotherapy, therapy, radiation

    Undergo radiation therapy

  • bevacizumabBiological

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

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00305877
Study groupRoleWhat they receive
Arm I (cetuximab, gemcitabine, capecitabine, radiation)ExperimentalPatients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
Receives: Biological: cetuximab; Drug: gemcitabine hydrochloride; Drug: capecitabine; Radiation: radiation therapy; Other: laboratory biomarker analysis
Arm II (bevacizumab, gemcitabine, capecitabine, radiation)ExperimentalPatients receive bevacizumab IV over 60-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in arm I.
Receives: Drug: gemcitabine hydrochloride; Drug: capecitabine; Radiation: radiation therapy; Biological: bevacizumab; Other: laboratory biomarker analysis

What is being measured

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

  1. Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy

    Specific toxicities to be monitored pursuant to the primary endpoint include:

    1. Any grade 5 toxicities
    2. Grade 4 dyspnea, neutropenic fever, allergic reaction, rash, wound dehiscence, wound infection, hypertension
    3. Grade 3 or higher arterial thromboembolic phenomena, bleeding, phlebitis/deep vein thrombosis (DVT)/pulmonary embolism (PE), hemorrhage, ileus, bowel perforation, diarrhea, and mucositis
    4. ECOG performance status decline by 2 or greater for >24 hours
    5. Weight loss >10%

    Measured: Every 2 weeks while on treatment and for 30 days after the end of treatment

Secondary outcomes (2)

  1. Two-year Overall Survival Rate

    Overall survival (OS) is defined as the time from randomization to death from any cause, or censored at last known date of survival.

    Measured: Assessed every 3 months for 2 years

  2. Two-year Disease-free Survival (DFS)

    Disease-free survival (DFS) is defined as the time from randomization to the first treatment failure (recurrence or death before recurrence).

    Measured: Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 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 Mar 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionJul 2008
  4. Study completionFeb 2012

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00305877
Sponsor's protocol ID
NCI-2012-02969
Other IDs
NCI-2012-02969, CALGB-ECOG-E2204, SWOG-ECOG-E2204, ECOG-E2204, NCCTG-ECOG-E2204, E2204, E2204, U10CA021115
Status last verified
Dec 2012
First submitted
21 Mar 2006
Last updated
21 May 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab, gemcitabine hydrochloride and capecitabine in people with Stage IA Pancreatic Cancer and Stage IB Pancreatic Cancer, 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 28 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 21 May 2014. 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?

Yes. Results are posted in the registry (first posted 25 Nov 2013). 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?

Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy (time frame: Every 2 weeks while on treatment and for 30 days after the end of treatment). 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 NCT00305877.

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 21 May 2014.

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