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Head and Neck CancerNCT00415298

AP5346 or Oxaliplatin in Treating Patients With Metastatic and/or Unresectable Recurrent Head and Neck Cancer

A study testing DACH polymer platinate AP5346, oxaliplatin and gene expression analysis in people with Head and Neck Cancer, run by University of California, San Diego at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as AP5346 and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
DACH polymer platinate AP5346, oxaliplatin and gene expression analysis
Type of treatment
Surgery or procedure
How many people
12 participants
Where
1 siteUnited States
Study dates
May 2006to not given
Phase
Interventional
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 primary squamous cell carcinoma of the head and neck, including the oral cavity, oropharynx, hypopharynx, larynx, or nasopharynx
  • Metastatic and/or unresectable locally recurrent disease for which no curative treatment is available
  • Patients must not be candidates for surgical resection or radiotherapy with curative intent
  • Histological documentation of relapse required, especially for locoregional recurrence or recurrence in a previously irradiated field
  • Tumor(s) must be amenable to minimally invasive biopsy during the first course of treatment
  • Must have evidence of progression or appearance of a new lesion after completion of radiotherapy, if biopsy site is in a previously irradiated field

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Absolute neutrophil count ≥ 2,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL
  • Bilirubin < 1.5 times upper level of normal (ULN)
  • Alkaline phosphatase (AP) ≤ 5 times normal (unless elevation is due to bone disease or bone metastasis in the absence of liver disease)
  • AST and ALT ≤ 3 times ULN
  • AST and ALT > 3 times ULN allowed provided AP ≤ 3 times ULN
  • Blood urea < 1.5 times ULN
  • Creatinine < 1.5 times ULN OR creatinine clearance > 60 mL/min OR creatinine clearance by 24-hour urine collection normal
  • Calcium normal
  • No history of hypersensitivity reactions of any kind to cisplatin or carboplatin
  • No other serious medical condition or psychiatric illness that would preclude the patient's ability to give informed consent or receive study treatment
  • No symptomatic peripheral neuropathy ≥ grade 2
  • No need for IV alimentation
  • No other serious illness or medical condition, including, but not limited to, the following:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris or cardiac arrhythmia
  • Significant neurologic or psychiatric disorders, including dementia or uncontrolled seizures
  • Hypophosphatemia

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior and no other concurrent anticancer treatment (i.e., chemotherapy, chemoradiotherapy, or radiotherapy)
  • At least 4 weeks since prior biologic therapy
  • No prior oxaliplatin
  • Prior cisplatin or carboplatin allowed
  • No concurrent anticoagulants other than cardioprotective doses of aspirin, cyclooxygenase 1-inhibitory nonspecific anti-inflammatory drugs, or prophylactic low-dose heparin
  • Concurrent bisphosphonates for hypercalcemia allowed provided the drug was initiated ≥ 3 months prior to study entry

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

Other trials in United States

About this study

Official title: AP5346 for Recurrent/Unresectable Squamous Cell Carcinoma of the Head and Neck: A Pilot Study With Clinical and Biological Endpoints

RATIONALE: Drugs used in chemotherapy, such as AP5346 and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This randomized clinical trial is studying the dose of AP5346 to see how well it works compared with the dose of oxaliplatin in treating patients with metastatic and/or unresectable recurrent head and neck cancer.

Read the detailed description

OBJECTIVES:

  • Compare the delivered-dose of platinum per gram of wet weight from a single dose of AP5346 vs a single dose of oxaliplatin in patients with metastatic and/or unresectable recurrent squamous cell carcinoma of the head and neck (SCCHN).
  • Correlate platinum accumulation in the tumor and tumor DNA with clinical response in patients treated with these regimens.
  • Correlate platinum accumulation in the tumor and tumor DNA with molecular tumor response as determined by GADD153 expression in patients treated with these regimens.
  • Quantify, by immunohistochemistry, the expression of the copper transporters CTR1, ATP7A, and ATP7B in SCCHN tumors and correlate expression of these transporters with tumor platinum levels.
  • Determine response in patients treated with AP5346.
  • Obtain additional data on the safety of AP5346 in these patients.

OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive AP5346 IV over 2 hours three times daily on days 1 and 15.
  • Arm II: Patients receive a single dose of unmodified oxaliplatin IV over 2 hours on day 1.

Beginning on day 29, all patients may receive AP5346 as in arm I. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor biopsy before and 24 hours after the first course of treatment for correlative pharmacological, immunohistochemical (IHC), and molecular studies. Tumor specimens are assessed for platinum content, GADD153 gene expression (by molecular analysis), and copper transporter (CTR1, ATP7A, ATP7B) expression by IHC.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

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, stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the oropharynx, 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
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

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

What is being measured

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

  1. Delivered-dose of platinum 24 hours after IV injection of a single dose of AP5346 vs a single dose of oxaliplatin

  2. Correlation of platinum accumulation in the tumor and tumor DNA with clinical response

  3. Correlation of platinum accumulation in the tumor and tumor DNA with molecular response as determined by GADD153 expression

  4. Quantification of expression of CTR1, ATP7A, and ATP7B in squamous cell carcinoma of the head and neck (SCCHN) tumors by immunohistochemistry

  5. Correlation of expression of CTR1, ATP7A, and ATP7B in SCCHN tumors with tumor platinum levels

  6. Toxicity of AP5346

Timeline

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

  1. First posted22 Dec 2006 (estimated)
  2. Study startMay 2006

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00415298
Sponsor's protocol ID
CDR0000520463
Other IDs
UCSD-HRPP-050275
Status last verified
May 2007
First submitted
20 Dec 2006
Last updated
10 Jan 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing DACH polymer platinate AP5346, oxaliplatin and gene expression analysis in people with Head and Neck Cancer, run by University of California, San Diego 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?

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: status not confirmed, as of the sponsor's last update on 10 Jan 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.

Are results available for this study?

Results are not available in the source record.

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?

Delivered-dose of platinum 24 hours after IV injection of a single dose of AP5346 vs a single dose of oxaliplatin. The study lists 6 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 NCT00415298.

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 10 Jan 2014.

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