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AzTrials

Colorectal CancerPhase 1NCT00062348

Boronophenylalanine-Fructose Complex (BPA-F) and/or Sodium Borocaptate (BSH) Followed By Surgery in Treating Patients With Thyroid Cancer, Head and Neck Cancer, or Liver Metastases

A Phase 1 study testing boronophenylalanine-fructose complex, sodium borocaptate and conventional surgery in people with Colorectal Cancer and Head and Neck Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Germany.

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: Diagnostic procedures using boronophenylalanine-fructose complex (BPA-F) and/or sodium borocaptate (BSH) to detect the presence of boron in tumor cells may help determine whether patients who have thyroid cancer, head and neck cancer, or liver metastases may benefit from boron neutron capture therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
boronophenylalanine-fructose complex, sodium borocaptate and conventional surgery
Type of treatment
Surgery or procedure
How many people
27 participants
Where
1 siteGermany
Study dates
Apr 2003to Dec 2007
Phase
Phase 1
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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed solid tumor of 1 of the following malignant tumor types:
  • Squamous cell cancer of the head and neck
  • Thyroid cancer
  • Liver metastases* secondary to colorectal adenocarcinoma NOTE: *Liver metastases are eligible provided colorectal adenocarcinoma has been histopathologically proven and CT scan/MRI shows metastatic lesions in the liver
  • Operable disease for which a surgical excision is planned
  • Primary, metastatic, or locally recurrent disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic

  • Bilirubin no greater than 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN
  • AST and ALT no greater than 2.5 times ULN
  • No other severe liver function impairment

Renal

  • Creatinine normal
  • BUN normal

Cardiovascular

  • No congestive heart failure
  • No angina pectoris
  • No recent coronary artery disease
  • No uncontrolled arrhythmias
  • No conduction defects
  • No other severe heart disease

Pulmonary

  • No severe obstructive or restrictive lung disease

Gastrointestinal

  • No severe gastrointestinal disease
  • No active peptic ulcer disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No pre-existing serious mental or organic brain disease (e.g., epilepsy)
  • No history of phenylketonuria (only in the case of BPA administration)
  • No severe allergic disease requiring continuous medication
  • No other concurrent severe disease
  • No uncontrolled endocrine disease
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 3 months since prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the malignant site

Surgery

  • See Disease Characteristics

Other

  • Recovered from prior antitumor therapy (excluding alopecia)
  • No concurrent anticancer treatment or agents

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitaetsklinikum Essen

    Essen, D-45122

Other trials in Germany

About this study

Official title: B-Uptake In Different Tumours Using The Boron Compounds BSH And BPA

RATIONALE: Diagnostic procedures using boronophenylalanine-fructose complex (BPA-F) and/or sodium borocaptate (BSH) to detect the presence of boron in tumor cells may help determine whether patients who have thyroid cancer, head and neck cancer, or liver metastases may benefit from boron neutron capture therapy.

PURPOSE: This phase I trial is studying the side effects of giving BPA-F and/or BSH before surgery to detect boron uptake in tissues of patients with primary, metastatic, or recurrent thyroid cancer, head and neck cancer, or liver metastases from colorectal cancer.

Read the detailed description

OBJECTIVES:

  • Identify additional solid tumors that may benefit from boron neutron capture therapy.
  • Determine the boron concentration in the tumor, surrounding tissues, and blood of patients with operable thyroid cancer, squamous cell cancer of the head and neck, or liver metastases secondary to colorectal adenocarcinoma who receive boronophenylalanine-fructose complex (BPA-F) and/or sodium borocaptate (BSH) before surgical resection.
  • Determine the feasibility of using these drugs to obtain a favorable absolute boron-10 concentration in the tumor and optimal tumor-to-blood and tumor-to-healthy tissue boron-10 rates in these patients.
  • Determine the qualitative and quantitative toxicity of combined BPA-F and BSH administration in these patients.

OUTLINE: This is a multicenter study. Patients are sequentially assigned to 1 of 3 treatment groups.

  • Group I: Patients receive boronophenylalanine-fructose complex (BPA-F) IV over 1 hour. Two hours later, patients undergo surgical resection.
  • Group II: Patients receive sodium borocaptate (BSH) IV over 1 hour. Twelve hours later, patients undergo surgical resection.
  • Group III: Patients receive BSH IV over 1 hour (administered 12 hours prior to surgery) and BPA-F IV over 1 hour (administered 2 hours prior to surgery). Patients then undergo surgical resection.

During the planned surgery, tissue samples from the tumor and surrounding tissues are collected.

Patients are followed on days 1 and 5 and then at 4 weeks.

PROJECTED ACCRUAL: A maximum of 27 patients will be accrued for this study.

Being tested
boronophenylalanine-fructose complex, sodium borocaptate, conventional surgery
Keywords
recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, untreated metastatic squamous neck cancer with occult primary, recurrent thyroid cancer, stage IV follicular thyroid cancer, stage IV papillary thyroid cancer, stage IVA colon cancer, stage IVB colon cancer, recurrent colon cancer, adenocarcinoma of the colon
Medical subject headings
Colorectal Neoplasms, Head and Neck Neoplasms, Neoplasm Metastasis, Squamous Cell Carcinoma of Head and Neck, Thyroid Neoplasms, Adenocarcinoma, Follicular, Thyroid Cancer, Papillary, Colonic Neoplasms

What participants receive

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

  • boronophenylalanine-fructose complexDrug

  • sodium borocaptateDrug

  • conventional surgeryProcedure or surgery

What is being measured

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

  1. Boron uptake ratio in tumor vs normal tissue

Secondary outcomes (1)

  1. Toxicity measured by NCI-CTC v2.0 up to 28 days after injections

Timeline

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

  1. First posted6 Jun 2003 (estimated)
  2. Study startApr 2003
  3. Primary completionDec 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 1
Primary purpose
Treatment
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00062348
Sponsor's protocol ID
EORTC-11001
Other IDs
EORTC-11001
Status last verified
Jan 2012
First submitted
5 Jun 2003
Last updated
20 Jan 2012
Results posted
No

Publications

  • Wittig A, Sheu-Grabellus SY, Collette L, Moss R, Brualla L, Sauerwein W. BPA uptake does not correlate with LAT1 and Ki67 expressions in tumor samples (results of EORTC trial 11001). Appl Radiat Isot. 2011 Dec;69(12):1807-12. doi: 10.1016/j.apradiso.2011.02.018. Epub 2011 Feb 16.

    PubMed 21367608

  • Bendel P, Wittig A, Basilico F, Mauri PL, Sauerwein W. Metabolism of borono-phenylalanine-fructose complex (BPA-fr) and borocaptate sodium (BSH) in cancer patients--results from EORTC trial 11001. J Pharm Biomed Anal. 2010 Jan 5;51(1):284-7. doi: 10.1016/j.jpba.2009.08.018. Epub 2009 Aug 22.

    PubMed 19735988

  • Wittig A, Collette L, Appelman K, Buhrmann S, Jackel MC, Jockel KH, Schmid KW, Ortmann U, Moss R, Sauerwein WAG. EORTC trial 11001: distribution of two 10B-compounds in patients with squamous cell carcinoma of head and neck, a translational research/phase 1 trial. J Cell Mol Med. 2009 Aug;13(8B):1653-1665. doi: 10.1111/j.1582-4934.2009.00856.x. Epub 2009 Jul 10.

    PubMed 19602035

  • Wittig A, Collette L, Moss R, Sauerwein WA. Early clinical trial concept for boron neutron capture therapy: a critical assessment of the EORTC trial 11001. Appl Radiat Isot. 2009 Jul;67(7-8 Suppl):S59-62. doi: 10.1016/j.apradiso.2009.03.012. Epub 2009 Mar 25.

    PubMed 19372041

  • Wittig A, Malago M, Collette L, Huiskamp R, Buhrmann S, Nievaart V, Kaiser GM, Jockel KH, Schmid KW, Ortmann U, Sauerwein WA. Uptake of two 10B-compounds in liver metastases of colorectal adenocarcinoma for extracorporeal irradiation with boron neutron capture therapy (EORTC Trial 11001). Int J Cancer. 2008 Mar 1;122(5):1164-71. doi: 10.1002/ijc.23224.

    PubMed 17985341

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing boronophenylalanine-fructose complex, sodium borocaptate and conventional surgery in people with Colorectal Cancer and Head and Neck Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Germany.

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 20 Jan 2012. 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Boron uptake ratio in tumor vs normal tissue. 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 NCT00062348, which also lists 5 linked publications.

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 20 Jan 2012.

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