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Phase II Two Arm Trial of the Proteasome Inhibitor, PS-341 (Velcade™) 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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Phase II Two Arm Trial of the Proteasome Inhibitor, PS-341 (Velcade™) 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)


OBJECTIVES:

Primary

- Compare the activity of bortezomib in combination with irinotecan vs bortezomib alone
in patients with locally recurrent or metastatic squamous cell carcinoma of the head
and neck.

- Determine the response rate in patients treated with single-agent bortezomib followed
by irinotecan at time of disease progression.

Secondary

- Compare the toxicity of these regimens in these patients.

- Compare time to progression, overall survival, and response in patients treated with
these regimens.

- Evaluate the relationship between pre-treatment nuclear localization of nuclear factor
kappa-light-chain-enhancer of activated B cells (NF-kB), and NF-kB-regulated gene
expression in tissue (Cyclin D1, Inhibitor of Apoptosis Protein 1 (IAP1), B-cell
lymphoma-extra large (Bcl-XL), and Topoisomerase (Topo) I), and serum (Interleukin 6
(IL-6), IL-8, Growth-regulated oncogene-1 (GRO-1), and Vascular endothelial growth
factor (VEGF)) and response.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
Eastern Cooperative Oncology Group (ECOG) performance status (0 vs 1). Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Patients receive bortezomib intravenously (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.

Actual Accrual: A total of 71 patients have been enrolled onto the study.

Inclusion Criteria


Inclusion criteria:

- Histologically confirmed squamous cell carcinoma of the head and neck

- Locally recurrent or metastatic disease

- Recurrent or metastatic disease must be confirmed by biopsy after prior
disease-free interval

- Not amenable to potentially curative local therapies OR patient has refused local
therapies

- Measurable disease

- At least 1 unidimensionally measurable lesion > 20 mm by conventional techniques
OR > 10 mm by spiral computed tomography (CT) scan

- Biopsy confirmation required for target lesions limited to an irradiated
location

- 18 and over

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

- Whole Blood Cell (WBC) ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin normal

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) test measures the
amount of this enzyme in the blood. ALT is found mainly (ALT) ≤ 2.5 times upper limit
of normal

- Creatinine normal OR Creatinine clearance ≥ 60 mL/min

- Negative pregnancy test

- Fertile patients must use effective contraception

Exclusion criteria:

- World Health Organization (WHO) type II or III nasopharyngeal cancer

- Primary salivary gland cancer

- Known brain metastases

- Pregnant or nursing

- Unstable angina pectoris

- Peripheral neuropathy ≥ grade 2 within the past 2 weeks

- Other invasive malignancy within the past 5 years

- History of allergic reaction to bortezomib

- History of allergic reaction attributed to compounds of similar chemical or

- Ongoing or active infection

- Psychiatric illness or social situation that would preclude study compliance

- Other uncontrolled illness

- Less than 4 weeks since prior chemotherapy for recurrent or metastatic disease

- More than 1 prior chemotherapy regimen for recurrent or metastatic squamous cell
carcinoma of the head and neck

- Prior irinotecan

- Prior bortezomib

- Concurrent radiotherapy

- Concurrent cyclosporine

- Concurrent antiepileptics

- Other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate on Step 1

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Jill Gilbert, MD

Investigator Role:

Study Chair

Investigator Affiliation:

MBCCOP - LSU Health Sciences Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02953

NCT ID:

NCT00103259

Start Date:

July 2005

Completion Date:

August 2012

Related Keywords:

  • Head and Neck Cancer
  • 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 oropharynx
  • 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 oropharynx
  • recurrent metastatic squamous neck cancer with occult primary
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • untreated metastatic squamous neck cancer with occult primary
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Mercy Cancer Center at Mercy Medical CenterCanton, Ohio  44708
St. Rita's Medical CenterLima, Ohio  45801
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Veterans Affairs Medical Center - Chicago Westside HospitalChicago, Illinois  60612
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Greater Baltimore Medical Center Cancer CenterBaltimore, Maryland  21204
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
St. Luke's Cancer Network at St. Luke's HospitalBethlehem, Pennsylvania  18015
Center for Cancer Treatment & Prevention at Sacred Heart HospitalEau Claire, Wisconsin  54701
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
Saint Joseph's HospitalMarshfield, Wisconsin  54449
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's HospitalRhinelander, Wisconsin  54501
Saint Michael's Hospital Cancer CenterStevens Point, Wisconsin  54481
Marshfield Clinic - Wausau CenterWausau, Wisconsin  54401
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids CenterWisconsin Rapids, Wisconsin  54494
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001