Triciribine and Carboplatin in Ovarian Cancer
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Purpose
The main purpose of this study is to see if we can select patients based on their cancer characteristics, to determine if Triciribine (TCN) and carboplatin are safe and tolerable when given together, and to determine if this combination of drugs can help people with recurrent ovarian cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: Triciribine Drug: Carboplatin |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Leveraging a Clinico-Genomic Database to Match Patients to a Trial of Triciribine and Carboplatin: Changing Paradigms in Ovarian Cancer Clinical Research |
- Maximum Tolerated Dose (MTD) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]To determine the maximum tolerated dose of TCN-PM when combined with carboplatin in a Phase I clinical trial of biomarker-selected women with platinum-resistant, recurrent or persistent epithelial ovarian, fallopian tube and primary peritoneal cancer (OVCA).
- Overall Response Rate (ORR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The best overall response is the best time point response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest sum recorded since baseline).
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm.
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Response and progression will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST version 1-1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
- Progression Free Survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of progression or death, whichever occurs first.
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Response and progression will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST version 1-1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
- Duration of Stable Disease (SD) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum diameters while on study.
Response and progression will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST version 1-1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
| Estimated Enrollment: | 45 |
| Study Start Date: | October 2013 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Triciribine and Carboplatin Treatment
Phase I/II Clinical Trial Doses: The starting dose for this phase I study (dose level 1) will be TCN 15 mg/m2 on days 1, 8 and 15 and Carboplatin AUC 5. TCN will be escalated to 25, 35, then 45 mg/m2 if dose limiting toxicities (DLTs) are not encountered. Phase II: Treat 18 additional patients at the recommended Phase II dose of triciribine + carboplatin to confirm safety and tolerability and assess response rate and Progression Free Survival (PFS)
|
Drug: Triciribine
Triciribine (15, 25, 35, or 45 mg/m2) on days 1, 8, 15 every 21 days. To be given as a 60 minute IV infusion.
Other Names:
Drug: Carboplatin
Carboplatin will be administered on day 1 every 21 days, as a 30 minute IV infusion after completion of TCN.
Other Names:
|
Detailed Description:
A portion of the patient's cancer tissue, previously removed, will be analyzed for a specific protein (phosphorylated BCL-2 antagonist of cell death). If the patient is found to have high levels of this protein in their tumor, they may qualify to be in the study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- At least 18 years of age
- Histologically confirmed, measurable or non-measurable, recurrent or persistent, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma
- At least one prior regimen of chemotherapy, with no maximum number of chemotherapy cycles
- A serum creatinine ≤ 1.5 mg% obtained ≤ 2 weeks prior to entry
- Adequate hematologic reserve obtained ≤ 2 weeks prior to entry: leukocytes ≥ 3,000 mm^3; absolute neutrophil count ≥ 1500 mm^3; platelets ≥ 100,000 mm^3
- Adequate hepatocellular function: AST (SGOT) and ALT (SGPT) ≤ 3x upper limit of normal within institutional limits; bilirubin ≤ 1.5 mg/dl
- Gynecologic Oncology Group (GOG) Performance Status of 0, 1, or 2
- Life expectancy of at least 90 days
- The patient should be off chemotherapy, biologic therapy and radiation for 28 days.
- Neuropathy (sensory and motor) less than or equal to grade 1 per Common Toxicity Criteria (CTC) version 4
- Patient tumors must demonstrate high (>median) phospho-BAD levels on immunohistochemical-based analyses.
Exclusion Criteria:
- Prior TCN-PM therapy
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to TCN-PM
- Patients must be disease-free of prior invasive malignancies for >2 years with the exception of basal cell or squamous cell carcinoma of the skin.
- Inability to give informed consent
Contacts and Locations| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | Not yet recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Amber Herschberger 813-745-7272 amber.herschberger@moffitt.org | |
| Principal Investigator: Patricia L. Judson, M.D. | |
| Sub-Investigator: Sachin Apte, M.D. | |
| Sub-Investigator: Jesus Gonzalez-Bosquet, M.D. | |
| Sub-Investigator: Johnathan M. Lancaster, M.D., Ph.D. | |
| Sub-Investigator: Said M. Sebti, Ph.D. | |
| Sub-Investigator: Robert M. Wenham, M.D. | |
| Principal Investigator: | Patricia L. Judson, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT01690468 History of Changes |
| Other Study ID Numbers: | MCC-17035 |
| Study First Received: | September 19, 2012 |
| Last Updated: | June 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female |
Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013