Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical C… (NCT00848016) | Clinical Trial Compass
CompletedPhase 2
Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery
United States29 participantsStarted 2009-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically confirmed adrenocortical carcinoma
* Recurrent, metastatic, or primary unresectable disease
* Measurable disease, defined as ≥ 1 lesion accurately measured in ≥ 1 dimension as ≥ 2.0 cm by conventional techniques or ≥ 1.0 cm by spiral CT scan
* No adrenocortical tumors that, in the Principal Investigator's opinion, are potentially resectable by surgical excision alone
* No symptomatic or progressive brain metastases
* Patients with treated brain metastases ≥ 6 months prior to study who are clinically and radiographically stable or improved and are off steroids are eligible
* Must undergo an MRI of the brain or CT scan of the head with contrast ≤ 4 weeks prior to study
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 or Karnofsky PS 60-100%
* Life expectancy ≥ 12 weeks
* White blood cell count (WBC) ≥ 3,000/mm3
* Absolute neutrophil count (ANC) ≥ 1,500/mm3
* Platelet count ≥ 100,000/mm3
* Total bilirubin \< 1.5 mg/dL
* Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal
* Serum creatinine ≤ 1.7 mg/dL or creatinine clearance ≥ 40 mL/min
* Able to take oral medications on a regular basis
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception prior to, during, and for ≥ 1 month after completion of study treatment
* No HIV positivity
* No uncontrolled intercurrent illness including, but not limited t…
What they're measuring
1
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