A Study of AT-101 in Combination With Docetaxel in Squamous Cell Carcinoma Of The Head and Neck

NCT01285635 | Terminated Phase 2 Results DMC

• 2 other identifiers: UMCC 2010.031HUM00040432
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

This study will examine the effects of an investigational drug called AT-101 in combination with an FDA approved cancer drug called Docetaxel. It is hoped that AT-101 will help the Docetaxel to have a better effect in slowing or stopping cancer cell growth. This study will help the researchers learn what effects, if any, the combination of AT-101 and Docetaxel has on your cancer. For instance, will the combination cause your tumor(s) to shrink or stop growing? The researchers will also learn about the safety of the combination of AT-101 and Docetaxel. For instance, are there any side effects? If so, what kind of side effects does the combination cause? How severe are the side effects, and how often do they occur?

Conditions

Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Outcome Measures

Primary Outcomes (1)

• Number of Patients With a Complete Response (CR) and Partial Response (PR)

  The primary objective is to estimate the proportion of patients with a complete response (CR) and partial response(PR) defined by RECIST (Response Evaluation Criteria in Solid Tumors). CR is defined as the disappearance of all target lesions and PR is defined as at least a 20% decrease in the sum of the longest diameter of target lesions.

  12 months

Secondary Outcomes (4)

• Median Duration of Response For All Groups Combined

  3 years

• Incidence of Grade 3 and 4 Toxicities by Arm

  3 years

• Median Overall Survival in Months

  3 Years

• Median Progression Free Survival in Months

  3 Years

Study Arms (3)

Docetaxel Alone

ACTIVE COMPARATOR

Drug: Docetaxel

Pulse Dose AT-101 Arm

EXPERIMENTAL

Drug: AT-101; Drug: Docetaxel

Metronomic AT-101 Arm

EXPERIMENTAL

Drug: AT-101; Drug: Docetaxel

Interventions

AT-101 DRUG

Pulse Dose: AT-101 dose of 40 mg b.i.d. on days 1-3 Metronomic Dose: AT-101, 20 mg daily, days 1-14

Metronomic AT-101 Arm; Pulse Dose AT-101 Arm

Docetaxel DRUG

Docetaxel 75 mg/m2 on Cycle Day 1

Docetaxel Alone; Metronomic AT-101 Arm; Pulse Dose AT-101 Arm

Eligibility Criteria

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

You may qualify if:

• Males and non-pregnant, non-lactating females at least 18 years old.
• Histologically or cytologically confirmed diagnosis of SCCHN (Squamous Cell Carcinoma of the Head and Neck).
• Stage IVC (metastatic), or advanced, locally recurrent SCCHN not amenable to surgery or palliative radiotherapy.
• 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
• 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.
• ECOG performance status ≤ 1 (Appendix 2)
• Expected survival of at least 3 months
• 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

You may not qualify if:

• Pregnant or nursing women.
• Prior docetaxel treatment for SCCHN in the metastatic setting.
• 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.
• 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.
• 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.
• 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.
• Any concurrent therapy intended to treat SCCHN.
• Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
• Symptomatic hypercalcemia or hypercalcemia that is \> Grade 2.
• 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).
• 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).
• 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.
• Patients who are contraindicated for treatment with docetaxel.
• 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.
• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (2)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

gossypol acetic acid; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. Francis Worden, M.D.
• Organization: University of Michigan Cancer Center

fworden@umich.edu

734-936-0453

Study Officials

• Francis Worden, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 28, 2011
• Study Start: June 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: September 1, 2015
• Last Updated: March 31, 2016
• Results First Posted: July 23, 2015

Record last verified: 2016-03

Locations

US (2)