OGX-011 and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Solid Tumors

NCT00471432 | Completed Phase 1 DMC

• 4 other identifiers: I154CAN-NCIC-IND154ONCOGENEX-OGX-01-02CDR0000547039
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: OGX-011 may kill tumor cells by blocking some of the proteins that may cause tumor cells to grow. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving OGX-011 together with docetaxel may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of OGX-011 when given together with docetaxel in treating patients with metastatic or locally recurrent solid tumors.

Conditions

Bladder Cancer; Breast Cancer; Kidney Cancer; Lung Cancer; Ovarian Cancer; Prostate Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

recurrent prostate cancer; stage IV prostate cancer; recurrent renal cell cancer; stage IV renal cell cancer; recurrent non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent bladder cancer; stage IV bladder cancer; recurrent breast cancer; stage IV breast cancer; recurrent ovarian epithelial cancer; stage IV ovarian epithelial cancer; unspecified adult solid tumor, protocol specific; male breast cancer

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity

• Recommended phase II dose of OGX-011

Secondary Outcomes (3)

• Pharmacokinetic profile

• Serum clusterin levels and clusterin expression in peripheral blood mononuclear cells and accessible tumors

• Objective response

Interventions

custirsen sodium DRUG

docetaxel DRUG

pharmacological study OTHER

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumors that have been shown to overexpress clusterin, including but not limited to, any of the following: * Prostate cancer * Renal cell carcinoma * Non-small cell lung cancer * Bladder cancer * Breast cancer * Ovarian cancer * Metastatic or locally recurrent disease * Refractory to standard curative therapy or no standard curative therapy exists * Patients with prostate cancer must be hormone refractory (i.e., have documented evidence of progression while receiving androgen ablative therapy) * Measurable or nonmeasurable disease * Measurable disease defined as measurable lesion ≥ 20 mm by x-ray, physical exam, or nonspiral CT scan or ≥ 10 mm by spiral CT scan * No documented CNS metastases * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * Absolute granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin normal * Creatinine ≤ 2 times upper limit of normal (ULN) * AST and ALT ≤ 1.5 times ULN * PT/INR and PTT normal * No uncontrolled pain * No known bleeding disorder * No history of serious allergic reaction to taxane (paclitaxel or docetaxel) * No preexisting peripheral neuropathy ≥ grade 2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other serious illness or medical conditions that would preclude study compliance, including any of the following: * Active uncontrolled infection * Significant cardiac dysfunction * No significant neurological disorder that would preclude giving informed consent PRIOR CONCURRENT THERAPY: * No prior strontium chloride Sr 89 * No more than 2 prior chemotherapy regimens, including adjuvant or neoadjuvant chemotherapy (for patients assigned to schedule B \[docetaxel once every 3 weeks\]) * More than 4 weeks since prior chemotherapy and recovered * At least 4 weeks since prior antiandrogens * More than 4 weeks since prior external-beam radiotherapy, except low-dose nonmyelosuppressive radiotherapy * No prior radiotherapy to ≥ 30% of marrow-bearing areas (for patients assigned to schedule B \[docetaxel once every 3 weeks\]) * At least 28 days since prior new anticancer therapy * At least 28 days since prior and no other concurrent investigational agents * No concurrent radiotherapy, except low-dose nonmyelosuppressive radiotherapy * No other concurrent cytotoxic therapy * Concurrent luteinizing hormone-releasing hormone agonist allowed (if already initiated in patients with prostate cancer) * No concurrent anticoagulant therapy (i.e., heparin, warfarin)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Related Publications (1)

• Chi KN, Siu LL, Hirte H, Hotte SJ, Knox J, Kollmansberger C, Gleave M, Guns E, Powers J, Walsh W, Tu D, Eisenhauer E. A phase I study of OGX-011, a 2'-methoxyethyl phosphorothioate antisense to clusterin, in combination with docetaxel in patients with advanced cancer. Clin Cancer Res. 2008 Feb 1;14(3):833-9. doi: 10.1158/1078-0432.CCR-07-1310.

  PMID: 18245546 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Breast Neoplasms; Kidney Neoplasms; Lung Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Ovarian Epithelial; Breast Neoplasms, Male

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Kidney Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Kim N. Chi, MD

  British Columbia Cancer Agency

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 10, 2007
• Study Start: April 4, 2003
• Primary Completion: March 9, 2006
• Study Completion: December 21, 2009
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share