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Recurrent Squamous Cell Carcinoma of the HypopharynxPhase 2NCT00103259

Bortezomib With or Without Irinotecan in Treating Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 2 study testing bortezomib, irinotecan hydrochloride and laboratory biomarker analysis in people with Recurrent Squamous Cell Carcinoma of the Hypopharynx and Recurrent Squamous Cell Carcinoma of the Larynx, 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 bortezomib and irinotecan to see how well they work compared to bortezomib alone in treating patients with locally recurrent or metastatic squamous cell carcinoma of the head and neck. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bortezomib, irinotecan hydrochloride and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteUnited States
Study dates
Jul 2005to Nov 2011
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 may have had one (0-1) prior chemotherapy regimen for recurrent or metastatic SCCHN; chemotherapy for recurrent or metastatic disease must have been completed at least 4 weeks prior to study entry
  • Patients must not have been previously treated with irinotecan or bortezomib
  • Patients must not be receiving radiation treatment
  • Patients must have histologically confirmed squamous cell carcinoma of the head and neck
  • Patients must have biopsy for histological confirmation of recurrent or metastatic disease if disease is now recurrent or metastatic after prior disease free-interval
  • NOTE: If patient has had a complete response (of any duration) but now has suspected recurrent disease (regardless of the time interval), the patient will need a biopsy for confirmation of SCCHN
Show all 38Show fewer
  • Disease must not be amenable to potentially curative local therapies or patient must have refused such options
  • Patients must not have nasopharyngeal subtypes WHO II or III. Patients may have nasopharyngeal WHO I; salivary gland primaries are excluded from study SUBTYPES OF NASOPHARYNGEAL CARCINOMA (NPC) WHO type 1 - keratinizing SCC WHO type 2 - nonkeratinizing epidermoid carcinoma WHO type 3 - undifferentiated carcinoma
  • Patients must have measurable disease
  • Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study
  • Measurable disease limited to a pre-irradiated location must be biopsy proven to be squamous cell carcinoma
  • Must have at least one objective measurable disease parameter; baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; all areas of disease should be recorded and mapped out in order to assess response and uniformity of response to therapy
  • Radiographic findings are acceptable providing that clear-cut measurement can be made
  • Measurable disease limited to a pre-irradiated location must be biopsy-proven to be squamous cell carcinoma
  • Patients must have ECOG performance status 0 or 1
  • Patients must not have grade 2 or higher peripheral neuropathy within 2 weeks of study entry
  • Leukocytes >= 3,000/uL
  • Absolute neutrophil count >= 1,500/uL
  • Platelets >= 100,000/uL
  • Total bilirubin within normal institutional limits
  • AST(SGOT) and ALT(SGPT) =< 2.5 x institutional upper limit of normal
  • Creatinine within normal institutional limits OR
  • Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Patients must have had no prior invasive malignancy unless the disease-free interval is 5 years or more
  • Women must not be pregnant or breast-feeding due to the fact that the teratogenic or abortifacient effects of PS-341are unknown; the effect of PS-341 on the nursing infant are also unknown; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
  • Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • Patients must not have history of allergic reactions to PS-341 or allergic reaction attributed to compounds of similar chemical or biologic composition to PS-341 including boron or mannitol
  • Patients must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
  • ELIGIBILITY FOR RE-REGISTRATION TO ARM A (FOR ARM B PATIENTS AT THE TIME OF PROGRESSION
  • Patients must have ECOG performance status 0 or 1
  • Leukocytes >= 3,000/uL
  • Absolute neutrophil count >- 1,500/uL
  • Platelets >= 100,000/uL
  • Total bilirubin within normal institutional limits
  • AST(SGOT) and ALT(SGPT) =< 2.5 x institutional upper limit of normal
  • Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events

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: Phase II Two Arm Trial of the Proteasome Inhibitor, PS-341 (Velcade TM) in Combination With Irinotecan or PS-341 Alone Followed by the Addition of Irinotecan at Time of Progression in Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

This randomized phase II trial is studying bortezomib and irinotecan to see how well they work compared to bortezomib alone in treating patients with locally recurrent or metastatic squamous cell carcinoma of the head and neck. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with irinotecan may kill more tumor cells. It is not yet known whether giving bortezomib together with irinotecan is more effective than bortezomib alone in treating head and neck cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the activity of combination of PS-341 (bortezomib) and irinotecan in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) and the response rate of single agent PS-341 (followed by irinotecan at time of progression).

SECONDARY OBJECTIVES:

  1. To continue exploring the toxicity of PS-341 alone and the combination of PS-341 and irinotecan in this patient population.

II. To evaluate time to progression, overall survival and response to irinotecan and PS-341 when given after PS-341 alone.

III. To evaluate the relationship between pre-treatment nuclear localization of NF-kB, and NF-kB regulated gene expression in tissue (Cyclin D1, IAP1, Bcl-XL, Topo I), and serum (IL-6, IL-8, GRO-1 and VEGF) and response.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Arm II: Patients receive bortezomib as in arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I.

Patients are followed every 3-6 months for up to 3 years.

Being tested
bortezomib, irinotecan hydrochloride, laboratory biomarker analysis
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Tongue Neoplasms

What participants receive

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

  • bortezomibDrug

    Also called LDP 341, MLN341, VELCADE

    Given IV

  • irinotecan hydrochlorideDrug

    Also called Campto, Camptosar, CPT-11, irinotecan

    Given IV

  • laboratory biomarker analysisOther

    Optional correlative studies

Study groups in NCT00103259
Study groupRoleWhat they receive
Arm I (bortezomib, irinotecan hydrochloride)ExperimentalPatients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Receives: Drug: bortezomib; Drug: irinotecan hydrochloride; Other: laboratory biomarker analysis
Arm II (bortezomib)ExperimentalPatients receive bortezomib as in arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I.
Receives: Drug: bortezomib; Other: laboratory biomarker analysis

What is being measured

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

  1. Response Rate on Step 1

    Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.

    Measured: Tumor response was assessed every 2 cycles until progression or intolerable toxicity with maximum of 3 years

Secondary outcomes (3)

  1. Response Rate on Step 2

    Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.

    Measured: Tumor response was assessed after every 2 cycles until progression or intolerable toxicity with maximum of 3 years

  2. Progression-free Survival on Step 1

    Progression-free survival was defined as time from registration to step 1 to disease recurrence or death from any cause, whichever occurred first. Disease progression was measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions.

    Measured: Every 3 months for first 2 years from protocol entry, then every 6 months until 3 years from study entry

  3. Overall Survival on Step 1

    Overall survival was defined as time from registration on step 1 to death from any cause. It was evaluated in all 61 eligible and treated patients.

    Measured: Survival was assessed every 3 month within 2 years and every 6 months betwen 2 and 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 posted8 Feb 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionNov 2011
  4. Study completionNov 2011

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
Double blind
Who is masked
Participant, Investigator
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00103259
Sponsor's protocol ID
NCI-2012-02953
Other IDs
NCI-2012-02953, E1304, E1304, U10CA021115
Status last verified
Dec 2012
First submitted
7 Feb 2005
Last updated
23 May 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bortezomib, irinotecan hydrochloride and laboratory biomarker analysis in people with Recurrent Squamous Cell Carcinoma of the Hypopharynx and Recurrent Squamous Cell Carcinoma of the Larynx, 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 38 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 23 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 27 Dec 2012). 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?

Response Rate on Step 1 (time frame: Tumor response was assessed every 2 cycles until progression or intolerable toxicity with maximum of 3 years). 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 NCT00103259.

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 23 May 2014.

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