SB-715992 in Treating Patients With Advanced or Metastatic Colorectal Cancer

NCT00103311 | Completed Phase 2 Results

• 3 other identifiers: NCI-2012-02834PHII-516800
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase II trial is studying how well SB-715992 works in treating patients with advanced or metastatic colorectal cancer. Drugs used in chemotherapy, such as SB-715992, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Conditions

Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IIIA Colon Cancer; Stage IIIA Rectal Cancer; Stage IIIB Colon Cancer; Stage IIIB Rectal Cancer; Stage IIIC Colon Cancer; Stage IIIC Rectal Cancer; Stage IVA Colon Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response (CR or PR) as Determined by the RECIST Criteria

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  Up to 5 years

Secondary Outcomes (2)

• Progression-free Survival

  From the date of registration to the date of documented PSA progression, assessed up to 6 months

• Overall Survival

  From the date of registration to the date of death, assessed up to 12 months

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive SB-715992 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: ispinesib; Other: laboratory biomarker analysis

Arm II

EXPERIMENTAL

Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: ispinesib; Other: laboratory biomarker analysis

Interventions

ispinesib DRUG

Given IV

Arm I; Arm II

laboratory biomarker analysis OTHER

Correlative studies

Arm I; Arm II

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed advanced/metastatic colorectal cancer
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan
• Patients must have received prior therapy (in any setting) with 5-FU, CPT-11, and oxaliplatin; patients may have received prior erbitux and bevacizumab, but it is not required
• Patients must have received at least one prior chemotherapy regimen for advanced disease
• Tumor must be accessible for biopsy or paraffin embedded tissue must be available for review of their biopsy specimen
• Life expectancy of \> 12 weeks
• ECOG performance status 0-2 (Karnofsky \>= 50%)
• Leukocytes \>= 3,000/μL
• Absolute neutrophil count \>= 1,500/μL
• Platelets \>= 100,000/μL
• Hemoglobin \>= 9 mg/dL
• Total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SGPT) =\< 2.5 X institutional upper limit of normal
• Creatinine =\< 1.5 X institutional upper limit of normal OR creatinine clearance \>= 60 mL/min/1.73 m\^2
• 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

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from AEs due to agents administered more than 4 weeks earlier
• Patients may not have received any other investigational agents within 28 days of study entry
• Patients may not receive other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) while on this study
• Prohibited medications; SB-715992 is a moderate to significant in vitro inhibitor of CYP3A4; the following lists of medications/substances are moderate to significant inhibitors/inducers of CYP3A4 that, if administered concomitantly with SB-715992, may alter study drug exposure; the use of these medications/substances within 14 days (\> 6 months for amiodarone) prior to the administration of the first dose of SB-715992 through discontinuation from the study is prohibited
• Inhibitors of CYP3A4:
• Antibiotics: clarithromycin, erythromycin, troleandomycin
• Antifungals: itraconazole, ketoconazole, fluconazole (doses \> 200 mg/day), voriconazole
• Antidepressants: nefazodone, fluovoxamine
• Calcium channel blockers: verapamil, diltiazem
• Miscellaneous: amiodarone\*, grapefruit juice, bitter orange
• Use of amiodarone within 6 months prior to the administration of the first dose of SB-715992 is prohibited
• Inducers of CYP3A4:
• Anticonvulsants: phenytoin, carbamazepine, Phenobarbital, oxcarbazepine
• Antibiotics: rifampin, rifabutin, rifapentine
• Miscellaneous: St. John's wort, modafinil

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Southern California, Norris

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

ispinesib

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: DCC Project Administrator
• Organization: California Cancer Consortium

CCCP@coh.org

626-256-4673

Study Officials

• Syma Iqbal, MD

  University of Southern California, Norris

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2005
• First Posted: February 8, 2005
• Study Start: January 1, 2005
• Primary Completion: January 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 2, 2015
• Results First Posted: March 2, 2015

Record last verified: 2013-10

Locations

US (1)