Clinical Trial: Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of the Orally Administered Negative Enantiomer of Gossypol (AT-101) in Patients With Advanced Adrenocortical Carcinoma (ACC)

Brief Summary: This phase II trial is studying how well gossypol acetic acid works in treating patients with recurrent, metastatic, or primary adrenocortical cancer that cannot be removed by surgery. Drugs used in chemotherapy such as gossypol acetic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed Summary:

PRIMARY OBJECTIVE:

I. To determine the proportion of patients with recurrent, metastatic, or primary unresectable adrenocortical carcinoma who achieve an objective response to R-(-)-gossypol acetic acid.

SECONDARY OBJECTIVES::

I. To evaluate the safety of this drug in these patients. II. To determine the progression-free and overall survival of these patients.

OUTLINE: This is a multicenter study.

Patients receive oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for up to 2 years.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: The Proportion of Patients Who Achieve a Confirmed Objective Response to Treatment, Either Partial Response (PR) or Complete Response (CR) as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria [ Time Frame: Up to 2 years ]

In order for a patient to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart. The proportion of patients who achieve a confirmed objective response to treatment will be estimated by the standard binomial estimator, i.e., the number of successes divided by the total number of evaluable patients.

Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.

Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD.



Original Primary Outcome: Proportion of patients who achieve a confirmed objective response (complete or partial response by RECIST criteria) to treatment

Current Secondary Outcome:

  • Overall Survival [ Time Frame: From registration to date of last follow-up or death due to any cause, assessed up to 2 years ]
    The overall survival time is defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the method of Kaplan-Meier.
  • Progression-free Survival [ Time Frame: From registration to progression or death, whichever occurs first, up to 2 years. ]
    The progression-free survival is defined as the time from registration to the date of progression or death, whichever comes first. The distributions of progression-free survival time will be estimated using the method of Kaplan-Meier.


Original Secondary Outcome:

  • Toxicity as assessed by NCI CTCAE v3.0
  • Time to progression and overall survival
  • Time to treatment failure and time to subsequent therapy
  • Duration of response


Information By: National Cancer Institute (NCI)

Dates:
Date Received: February 19, 2009
Date Started: February 2009
Date Completion:
Last Updated: April 17, 2014
Last Verified: January 2014