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Phase II Trial of PS-341 (NSC 681239) Followed by the Addition of Doxorubicin at Progression in Advanced Adenoid Cystic Carcinoma of the Head and Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Salivary Gland Cancer, Salivary Gland Adenoid Cystic Carcinoma, Stage III Adenoid Cystic Carcinoma of the Oral Cavity, Stage III Salivary Gland Cancer, Stage IV Adenoid Cystic Carcinoma of the Oral Cavity, Stage IV Salivary Gland Cancer

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Trial Information

Phase II Trial of PS-341 (NSC 681239) Followed by the Addition of Doxorubicin at Progression in Advanced Adenoid Cystic Carcinoma of the Head and Neck


OBJECTIVES: Primary I. Determine the objective tumor response in patients with locally
advanced, recurrent, or metastatic adenoid cystic carcinoma of the head and neck treated
with bortezomib.

Secondary I. Determine the time to progression in patients treated with this drug. II.
Determine the overall survival of patients treated with this drug. III. Determine the toxic
effects of this drug in these patients. IV. Determine the objective tumor response, time to
progression, and overall survival of patients who progress on single-agent bortezomib and
are then treated with doxorubicin and bortezomib.

V. Determine the toxic effects of this regimen in these patients. VI. Determine the profile
and concentration of inflammatory and angiogenic cytokines in serum of patients before and
in response to this regimen.

VII. Correlate the expression of biomarkers which may be affected by the
ubiquitin-proteasome degradation pathway (NF-kB, p53, p27, cyclin D1, cyclin E, vascular
endothelial growth factor [VEGF], MVD, V-CAM, and N-CAM) on tumor tissue with the clinical
activity of bortezomib in these patients.

OUTLINE: This is a multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity. Patients with
disease progression continue to receive bortezomib as above and doxorubicin IV over 2-5
minutes on days 1 and 8. Treatment repeats every 21 days for up to 14 courses in the absence
of further disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 8 years.

PROJECTED ACCRUAL: A total of 23-37 patients will be accrued for this study within 2.3
years.


Inclusion Criteria:



- Histologically confirmed adenoid cystic carcinoma of the head and neck

- Locally advanced, recurrent, or metastatic disease that is considered incurable
by known therapies

- Unidimensionally measurable disease

- Must not have stable disease for at least 9 months before study entry

- No known brain metastases

- Performance status - ECOG 0-2

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- AST and ALT no greater than 2.5 times upper limit of normal

- Bilirubin normal

- Creatinine normal

- Creatinine clearance at least 60 mL/min

- LVEF at least lower limit of normal by MUGA

- No history of congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No active or ongoing infection

- No prior allergy to compounds of similar chemical or biological composition to
bortezomib

- No other concurrent uncontrolled illness

- No psychiatric illness or social situation that would preclude study compliance

- No pre-existing neuropathy > grade 1

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
or carcinoma in situ of the cervix

- See Chemotherapy

- No prior anthracyclines, including any of the following:

- Doxorubicin

- Epirubicin

- Daunorubicin

- Idarubicin

- No prior mitoxantrone

- No prior high-dose chemotherapy for bone marrow transplantation

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

- At least 3 weeks since prior radiotherapy

- At least 3 weeks since prior surgery

- More than 4 weeks since prior investigational drugs

- No other concurrent anticancer therapy or agents

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response (complete and partial overall response) as defined by Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

Up to 10 years

Safety Issue:

No

Principal Investigator

Athanassios Argiris

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02574

NCT ID:

NCT00077428

Start Date:

June 2004

Completion Date:

Related Keywords:

  • Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
  • Recurrent Salivary Gland Cancer
  • Salivary Gland Adenoid Cystic Carcinoma
  • Stage III Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage III Salivary Gland Cancer
  • Stage IV Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage IV Salivary Gland Cancer
  • Carcinoma
  • Carcinoma, Adenoid Cystic
  • Salivary Gland Neoplasms
  • Disease Progression

Name

Location

Eastern Cooperative Oncology GroupBoston, Massachusetts  02215