Phase 2 Study of Docetaxel +/- OGX-427 in Patients With Relapsed or Refractory Metastatic Bladder Cancer
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ClinicalTrials.gov Identifier: NCT01780545 |
Recruitment Status :
Completed
First Posted : January 31, 2013
Results First Posted : November 14, 2017
Last Update Posted : July 11, 2022
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Condition or disease | Intervention/treatment | Phase |
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Bladder Cancer Urothelial Carcinoma | Drug: OGX-427 Drug: Docetaxel | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Borealis-2 Clinical Trial: A Randomized Phase 2 Study Comparing Docetaxel Alone to Docetaxel in Combination With OGX-427 in Patients With Relapsed or Refractory Metastatic Urothelial Carcinoma After Receiving a Platinum-containing Regimen: Hoosier Cancer Research Network GU12-160 |
Study Start Date : | April 2013 |
Actual Primary Completion Date : | October 2017 |
Actual Study Completion Date : | October 2017 |
Arm | Intervention/treatment |
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Experimental: Experimental Arm: Arm A
Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle.
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Drug: OGX-427
Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle. Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Participants without documented disease progression who have discontinued from study treatment not due to toxicity related to OGX-427 can also continue to receive OGX-427 maintenance as long as they have completed disease assessments following at least 2 cycles of chemotherapy. Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity. Drug: Docetaxel For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion. For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles. |
Active Comparator: Control Arm: Arm B
Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.
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Drug: Docetaxel
For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion. For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles. |
- Overall Survival [ Time Frame: 36 Months ]To determine whether docetaxel administered in combination with OGX-427 provides a survival benefit compared to docetaxel alone.
- Safety and Toxicity of Regimen [ Time Frame: 36 Months ]To compare the safety and toxicity of OGX-427 in combination with docetaxel to that of docetaxel alone. A summary of per-patient maxiumy grade adverse events of any type is included in the Outcome Measure. Full adverse event information will be submitted further in the record.
- Overall Response Rate [ Time Frame: Every 6 weeks ]To compare overall response rate (ORR) between the treatment arms.
- Overall Survival (OS) According to Baseline Serum Hsp27 Level. [ Time Frame: 36 months ]A subgroup analysis to determine the median overall survival time based on baseline Hsp27 levels.
- Hsp27 Expression in Archival Tissue [ Time Frame: Cycle 1 ]To evaluate the association of urothelial carcinoma expression of Hsp27 measured by immunohistochemistry (IHC) in archival tissue with clinical outcomes.
- Effect of Therapy Regimen on Circulating Tumor Cells (CTCs)and Correlative Analysis of Telomerase Activity [ Time Frame: Prior to screening, prior to first loading dose, and prior to cycles 1, 2, 3 and 5 ]To evaluate the effect of therapy with docetaxel and OGX-427 on peripheral blood circulating tumor cells (CTCs) enumeration and expression of Hsp27 and other relevant proteins via immunoflourescence, and levels of telomerase by quantitative polymerase chain reaction (PCR), and explore their relation with clinical outcomes.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants must have histologically documented metastatic or locally inoperable advanced urothelial carcinoma (bladder, urethra, ureter and renal pelvis) (T4b, N2, N3, or M1 disease. NOTE: Aberrant differentiation such as squamous, glandular (adenocarcinoma), and micropapillary are eligible unless the tumor is considered a pure histological variant according to the pathology report. Participants with small cell histology are not eligible.
- Participants must have measurable disease defined as at least one target lesion that has not been irradiated and can be accurately measured in at least one dimension by RECIST v1.1 criteria.
- Participants must have received prior systemic chemotherapy treatment for metastatic urothelial carcinoma. NOTE: Up to 2 prior systemic chemotherapeutic regimens given in the metastatic disease setting for urothelial carcinoma are allowed.
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Specifically, subjects must meet one or more of the following criteria:
- Progression during or after treatment with a regimen that includes a platinum salt (e.g., carboplatin or cisplatin) OR
- Disease recurrence within one year after neoadjuvant or adjuvant platinum-based systemic chemotherapy, measured from the date of last dose of chemotherapy or surgery until the day the informed consent is signed
- Participants must be ≥18 years since no dosing or adverse event data are currently available on the use of OGX-427 in participants <18 years of age.
- Minimum of 21 days have elapsed since prior major surgery, with recovery from any adverse events.
- Minimum of 14 days have elapsed since any prior radiation therapy, with recovery from any adverse events.
- The effects of OGX-427 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- History of treatment with docetaxel in any setting. Participants treated with prior paclitaxel are eligible.
- Prior enrollment in the OncoGenex Phase 2 Study OGX-427-02.
- Participants may not be receiving other investigational agents.
- Participants with known brain or spinal cord metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. NOTE: Brain imaging is not required unless the patient has symptoms or physical signs of central nervous system (CNS) disease.
- History of allergic reactions or severe hypersensitivity reactions to drugs formulated with polysorbate 80 or antisense oligonucleotides.
- Peripheral neuropathy ≥Grade 2.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.
- Cerebrovascular accident or pulmonary embolus within 3 months of randomization.
- Pregnant women and breast feeding women are excluded from this study because of the risk to a fetus due to docetaxel chemotherapy and OGX-427 systemic treatment (fertility toxicology studies have not been completed for OGX-427).
- Active second malignancy (except non-melanomatous skin cancer or incidental prostate cancer found on cystectomy): active secondary malignancy is defined as a current need for cancer therapy or a high possibility (>30%) of recurrence during the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01780545
Study Chair: | Noah Hahn, M.D. | Hoosier Cancer Research Network |
Documents provided by Noah Hahn, M.D., Hoosier Cancer Research Network:
Publications:
Responsible Party: | Noah Hahn, M.D., Sponsor-Investigator, Hoosier Cancer Research Network |
ClinicalTrials.gov Identifier: | NCT01780545 |
Other Study ID Numbers: |
GU12-160 |
First Posted: | January 31, 2013 Key Record Dates |
Results First Posted: | November 14, 2017 |
Last Update Posted: | July 11, 2022 |
Last Verified: | July 2022 |
OGX-427 Docetaxel |
Carcinoma Urinary Bladder Neoplasms Carcinoma, Transitional Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Urinary Bladder Diseases Urologic Diseases Male Urogenital Diseases Docetaxel Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |