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

NCT00103259 | Completed Phase 2 Results

• 3 other identifiers: NCI-2012-02953E1304U10CA021115
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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; Recurrent Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Larynx; Stage IV Squamous Cell Carcinoma of the Nasopharynx; Stage IV Verrucous Carcinoma of the Larynx; Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVA Squamous Cell Carcinoma of the Oropharynx; Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVA Verrucous Carcinoma of the Oral Cavity; Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVB Squamous Cell Carcinoma of the Oropharynx; Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVB Verrucous Carcinoma of the Oral Cavity; Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVC Squamous Cell Carcinoma of the Oropharynx; Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVC Verrucous Carcinoma of the Oral Cavity; Tongue Cancer

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

• Response Rate on Step 2

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

• Progression-free Survival on Step 1

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

• Overall Survival on Step 1

  Survival was assessed every 3 month within 2 years and every 6 months betwen 2 and 3 years

Study Arms (2)

Arm I (bortezomib, irinotecan hydrochloride)

EXPERIMENTAL

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

Drug: bortezomib; Drug: irinotecan hydrochloride; Other: laboratory biomarker analysis

Arm II (bortezomib)

EXPERIMENTAL

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.

Drug: bortezomib; Other: laboratory biomarker analysis

Interventions

bortezomib DRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE

Arm I (bortezomib, irinotecan hydrochloride); Arm II (bortezomib)

irinotecan hydrochloride DRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E

Arm I (bortezomib, irinotecan hydrochloride)

laboratory biomarker analysis OTHER

Optional correlative studies

Arm I (bortezomib, irinotecan hydrochloride); Arm II (bortezomib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Eastern Cooperative Oncology Group

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Tongue Neoplasms

Interventions

Bortezomib; Irinotecan

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids

Results Point of Contact

• Title: ECOG Statistician
• Organization: Eastern Cooperative Oncology Group (ECOG) Statistical Office

617-632-3012

Study Officials

• Jill Gilbert

  Eastern Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2005
• First Posted: February 8, 2005
• Study Start: July 1, 2005
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 23, 2014
• Results First Posted: December 27, 2012

Record last verified: 2012-12

Locations

US (1)