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A Phase II of AT-101 in Combination With Docetaxel in Patients With Recurrent, Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)


Phase 2
18 Years
N/A
Not Enrolling
Both
Squamous Cell Carcinoma of the Head and Neck (SCCHN)

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Trial Information

A Phase II of AT-101 in Combination With Docetaxel in Patients With Recurrent, Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)


Inclusion Criteria:



1. Males and non-pregnant, non-lactating females at least 18 years old.

2. Histologically or cytologically confirmed diagnosis of SCCHN (Squamous Cell Carcinoma
of the Head and Neck).

3. Stage IVC (metastatic), or advanced, locally recurrent SCCHN not amenable to surgery
or palliative radiotherapy.

4. Presence of measurable disease as defined by RECIST (Response Evaluation Criteria in
Solid Tumors)

a. If the only site of measurable disease for this study is within a prior field of
irradiation, then the sum of the longest diameter (SLD) of that lesion must have
increased by at least 20% from the prior treatment nadir

5. Received no more than two prior systemic chemotherapeutic regimen for SCHNN in the
locally advanced or metastatic setting and have relapsed after or be refractory to
therapy

- Systemic therapies given in the adjuvant setting or with chemoradiotherapy are
counted only if the patient relapses after 6 months of the last cycle of
chemotherapy or the completion of radiation

- Included as systemic chemotherapy regimens (but not limited to) are patients who
may have received erlotinib (Tarceva®) or another EGFR inhibitor. Previous
treatment with paclitaxel (but not docetaxel) is permitted.

6. ECOG performance status ≤ 1 (Appendix 2)

7. Expected survival of at least 3 months

8. Adequate liver and renal and bone marrow function as indicated by:

- Serum creatinine ≤ 2.0 times the upper limit of normal, AND

- Serum albumin ≥ 3.0 gm/dL, AND

- Total bilirubin ≤ 1.0 times the upper limit of normal, AND

- Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT)
≤ 2.5 times the upper limit of normal (ULN) for the testing laboratory. Note:
For patients with alkaline phosphatase ≥ 2.5 x ULN, the AST and ALT must be ≤
1.5 x ULN

- Hemoglobin ≥ 9 g/dL (may be post-transfusion);

- Platelet count ≥ 100 x103 cells/mm3

- Neutrophil count ≥1500 cells/mm3

9. Negative pregnancy test for females of childbearing potential

10. Willingness to use contraception by a method that is deemed effective by the
Investigator by both males and female patients of childbearing potential
(postmenopausal women must have been amenorrheal for at least 12 months to be
considered of non-childbearing potential) and their partners throughout the treatment
period and for at least 30 days following the last dose of AT-101

11. Ability to understand and the willingness to sign a written informed consent form;
the consent form must be signed by the patient prior to any study-specific procedures

12. Willingness and ability to comply with study procedures and follow-up examination

Exclusion Criteria:

1. Pregnant or nursing women.

2. Prior docetaxel treatment for SCCHN in the metastatic setting.

3. Treatment of SCCHN with chemotherapy within 28 days of the first dose of study
treatment. Acute toxicities from prior therapy must have resolved to Grade ≤ 1.
Patients whose disease responded to the most recently administered prior regimen must
have documented progression of disease subsequent to that regimen, to be eligible.

4. Treatment with monoclonal antibody (e.g., VEGF or EGFR targeting antibody) within 45
days prior to the first dose of study treatment. Acute toxicities from prior therapy
must have resolved to Grade ≤ 1. Patients whose disease responded to the most
recently administered prior regimen must have documented progression of disease
subsequent to that regimen, to be eligible.

5. Treatment of SCCHN with radiotherapy within 14 days of the first dose of study
treatment. Prior radiotherapy is permissible only if the lesions used for
determination of disease activity (i.e., target lesions) were not previously
irradiated, or have increased in size since the completion of radiotherapy, and the
patient has fully recovered from any toxicity of the radiotherapy.

6. Treatment of SCCHN with erlotinib within 14 days of the first dose of study
treatment. Acute toxicities from prior therapy must have resolved to Grade ≤ 1.
Patients whose disease responded to the most recently administered prior regimen must
have documented progression of disease subsequent to that regimen, to be eligible.

7. Any concurrent therapy intended to treat SCCHN.

8. Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional
Classification

9. Symptomatic hypercalcemia or hypercalcemia that is > Grade 2.

10. Participation in any investigational drug study within 28 days prior to study
treatment. (Patient must have recovered from all acute effects of previously
administered investigational agents).

11. Active secondary malignancy or history of other malignancy within the last five years
(patients who have been disease-free for five years, or have a history of completely
resected non-melanoma skin cancer or successfully treated in situ carcinoma are
eligible).

12. Active symptomatic fungal, bacterial and/or viral infection including active HIV.
Note: protocol does not require screening for viruses; however, patients with known
active infections are excluded.

13. Patients who are contraindicated for treatment with docetaxel.

14. Have malabsorption syndrome, disease significantly affecting gastrointestinal
function, or resection of the stomach or small bowel, ulcerative colitis,
inflammatory bowel disease, partial or complete small bowel obstruction.

15. Uncontrolled CNS (Central Nervous System) metastases. Patients with known, previously
treated CNS metastases are eligible if they are neurologically stable, as per the
investigating physician's clinical assessment, and do not require steroids at the
time of study entry.

16. Prior use of gossypol or AT-101, or known hypersensitivity to gossypol or AT-101.

17. Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

18. Any patient being treated for acute deep vein thrombosis or patients with a history
of recurrent deep vein thrombosis independent of treatment with anticoagulation.

19. Any other condition or circumstance that would, in the opinion of the Investigator,
make the patient unsuitable for participation in the study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients with a complete response, partial response, objective response, and clinical benefit as a measure of efficacy

Outcome Description:

To estimate the proportion of patients with a complete response (CR), partial response(PR), objective response (CR + PR), and clinical benefit (CR + PR + stable disease [SD]); to estimate the time to response and duration of response in responding patients.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Francis Worden, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

UMCC 2010.031

NCT ID:

NCT01285635

Start Date:

June 2010

Completion Date:

January 2014

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201