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Pancreatic CancerPhase 2NCT00376948

Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

A Phase 2 study testing genistein, erlotinib hydrochloride and gemcitabine hydrochloride in people with Pancreatic Cancer, run by Barbara Ann Karmanos Cancer Institute at 2 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: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 21 to 120 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
genistein, erlotinib hydrochloride and gemcitabine hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
May 2005to Mar 2010
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 21 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed pancreatic adenocarcinoma
  • Locally advanced or metastatic disease by radiological evidence
  • Must have biopsy material consisting of 10 unstained slides or paraffin-embedded tissue blocks available for correlative studies
  • No endocrine tumor or lymphoma of the pancreas
  • No history of CNS (central nervous system) metastases

PATIENT CHARACTERISTICS:

  • SWOG (Southwest Oncology Group) performance status 0-1
  • Life expectancy ≥ 12 weeks
  • Platelet count ≥ 100,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Bilirubin < 2.0 mg/dL
  • AST (aspartate aminotransferase) and ALT (alanine aminotransferase) < 1.5 times upper limit of normal
  • Creatinine < 1.5 mg/dL
  • Albumin > 2.5 g/dL
  • INR (international normalized ratio) < 1.3 (in the absence of ongoing treatment with warfarin)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection
  • No condition that would limit the ability to receive oral medications
  • No requirement for a gastrostomy tube for the administration of drugs
  • No serious concurrent systemic disorder, that, in the opinion of the investigator, is incompatible with the study
  • No active second primary malignancy within the past year except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin
  • No allergy to any study drug

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy for metastatic disease
  • Prior adjuvant chemotherapy allowed provided it was completed at least 6 months ago
  • No prior gemcitabine hydrochloride or epidermal growth factor receptor-inhibiting agents
  • No other concurrent chemotherapy, immunotherapy, tumor-directed hormonal therapy, or radiotherapy
  • No other concurrent investigational agents
  • No other concurrent antitumor therapy

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

Other trials in United States

About this study

Official title: Phase II Trial of Novasoy®, Gemcitabine, and Erlotinib in Locally Advanced or Metastatic Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genistein may help gemcitabine and erlotinib kill more tumor cells by making tumor cells more sensitive to the drugs.

PURPOSE: This phase II trial is studying how well giving genistein together with gemcitabine and erlotinib works in treating patients with locally advanced or metastatic pancreatic cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the 6-month survival rate of patients with locally advanced or metastatic pancreatic cancer treated with genistein, gemcitabine hydrochloride, and erlotinib hydrochloride.

Secondary

  • Determine the frequency of objective tumor response rate in these patients.
  • Determine the time to treatment failure in these patients.
  • Determine the effect of baseline expression of pAKT and activation of NF-kappaB on survival of patients treated with this regimen.
  • Determine the overall time to disease progression in these patients.
  • Estimate the quantitative and qualitative toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral genistein twice daily on days -7 to 28 in course 1 and on days 1-28 in all other courses. Patients also receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Being tested
genistein, erlotinib hydrochloride, gemcitabine hydrochloride
Keywords
adenocarcinoma of the pancreas, stage III pancreatic cancer, stage IV pancreatic cancer, recurrent pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

Study groups in NCT00376948
Study groupRoleWhat they receive
Novasoy®, Gemcitabine & ErlotinibExperimentalNovasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, \& 15; Erlotinib 150 mg day 1 until day 28
Receives: Dietary Supplement: genistein; Drug: erlotinib hydrochloride; Drug: gemcitabine hydrochloride

What is being measured

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

  1. Patients Alive

    Measured: at 6 months

  2. Median Overall Survival Estimate

    Measured: up to 17 months

Secondary outcomes (6)

  1. Overall Objective Response Rate (Complete and Partial Response)

    Imaging tests (CT scan, CXR [Chest X-Ray], MRI or imaging studies as clinically indicated

    Measured: Every 8 weeks

  2. Response Duration

    Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated). Progressive disesase is defined as a greater than 20% increase in the sum of the longest diameter of target lesions taking as reference the smalles sum of the longest diameter recorded since the treatment started or the appearance of new lesions. Partial response is defined as greater than or equal to 30% reduction in the sum of the longest diameteres of target lesions, taking as reference the baseline sum of the longest diameters.

    Measured: Every 8 weeks

  3. Time to Treatment Failure

    Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated). Progressive disesase is defined as a greater than 20% increase in the sum of the longest diameter of target lesions taking as reference the smalles sum of the longest diameter recorded since the treatment started or the appearance of new lesions.

    Measured: Every 8 weeks

  4. Time to Progression

    Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated). Progressive disesase is defined as a greater than 20% increase in the sum of the longest diameter of target lesions taking as reference the smalles sum of the longest diameter recorded since the treatment started or the appearance of new lesions.

    Measured: Every 8 weeks

  5. Grade 3 or Higher Toxicity Evaluation

    Toxicity evaluation using NCI-CTC (Common Terminology Criteria) v.3 criteria; CBC (complete blood count) with differential white cell and platelet counts; Serum sodium, potassium, chloride, bicarbonate, AST, ALT, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, and albumin; Serum CA 19-9

    Measured: First day of each cycle

  6. pAKT (Pichia Anomala Killer Toxin) and NF (Nuclear Factor)-kappaB Activation

    Tumor tissue collected from paraffin

    Measured: At start of study

Timeline

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

  1. First posted15 Sep 2006 (estimated)
  2. Study startMay 2005
  3. Primary completionMar 2010
  4. Study completionMar 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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00376948
Sponsor's protocol ID
CDR0000495776
Other IDs
P30CA022453, WSU-2005-006, WSU-025806MP4F
Status last verified
Feb 2021
First submitted
13 Sep 2006
Last updated
1 Mar 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing genistein, erlotinib hydrochloride and gemcitabine hydrochloride in people with Pancreatic Cancer, run by Barbara Ann Karmanos Cancer Institute at 2 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 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 26 Aug 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?

Patients Alive (time frame: at 6 months). The study lists 2 primary outcomes in all. 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 NCT00376948.

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 1 Mar 2021.

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