Phase 2
N=29
Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery
Recurrent Adrenocortical Carcinoma · Stage III Adrenocortical Carcinoma · Stage IV Adrenocortical Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00848016 ↗Enrolled (actual)
29
Serious AEs
37.9%
Results posted
Feb 2014
Primary outcome: Primary: 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 — 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- R-(-)-gossypol acetic acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
— | — |
| SECONDARY Overall Survival |
8.5 | — |
| SECONDARY Progression-free Survival |
1.9 | — |
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.
Eligibility Criteria
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 grade 2
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to R-(-)-gossypol acetic acid
- Fully recovered from prior surgical procedures and recovered to ≤ grade 1 from adverse events due to previous treatments
- No prior racemic gossypol or R-(-)-gossypol acetic acid
- More than 4 weeks since prior chemotherapy, biologic therapy, major surgery, or radiotherapy (≥ 6 weeks for carmustine or mitomycin C)
- Prior and concurrent mitotane and ketoconazole allowed for patients with hormonal excess
- More than 4 weeks since prior and no concurrent treatment with another investigational agent
- No concurrent prophylactic use of hematopoietic growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], interleukin-11) during the first course of study treatment
- Not requiring routine use of platelet transfusions to maintain ANC or platelet count above required thresholds
Exclusion Criteria
- No concurrent combination antiretroviral therapy for HIV-positive patients
Data sourced from ClinicalTrials.gov (NCT00848016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.