Sorafenib in Treating Patients With Advanced Solid Tumors

NCT00436579 | Terminated Phase 1

• 7 other identifiers: NCI-2009-00221UCCRC-15002ACDR000052826115002A7768U01CA069852P30CA014599
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase I trial is studying the side effects, such as high blood pressure, and best dose of sorafenib in treating patients with advanced solid tumors. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• Changes in BP

  BP will first be calculated for each subject as BP after 1 week of treatment minus BP before that treatment dose. Then, for each randomized group separately, the BP changes in the two study phases will be compared using paired t-tests.

  From baseline to day 21

Secondary Outcomes (3)

• Association between steady state trough levels of sorafenib and BP

  Days 8 and 22

• Toxicity rates in the two high dose groups

  Every 2 weeks, assessed up to 1 year

• Effect of sorafenib dose/exposure on thyroid function

  From baseline up to 50 days

Study Arms (3)

Arm I (higher-dose enzyme inhibitor therapy)

EXPERIMENTAL

Patients receive higher-dose oral sorafenib tosylate twice daily on days 15-36.

Drug: sorafenib tosylate; Other: pharmacological study; Procedure: assessment of therapy complications; Other: laboratory biomarker analysis

Arm II (standard-dose enzyme inhibitor therapy)

ACTIVE COMPARATOR

Patients receive standard-dose oral sorafenib tosylate three times daily on days 15-36.

Drug: sorafenib tosylate; Other: pharmacological study; Procedure: assessment of therapy complications; Other: laboratory biomarker analysis

Arm III (standard-dose enzyme inhibitor therapy)

ACTIVE COMPARATOR

Patients receive standard-dose oral sorafenib tosylate twice daily on days 15-36. (closed to accrual as of 4/29/2009)

Drug: sorafenib tosylate; Other: pharmacological study; Procedure: assessment of therapy complications; Other: laboratory biomarker analysis

Interventions

sorafenib tosylate DRUG

Given orally

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN

Arm I (higher-dose enzyme inhibitor therapy); Arm II (standard-dose enzyme inhibitor therapy); Arm III (standard-dose enzyme inhibitor therapy)

pharmacological study OTHER

Also known as: pharmacological studies

Arm I (higher-dose enzyme inhibitor therapy); Arm II (standard-dose enzyme inhibitor therapy); Arm III (standard-dose enzyme inhibitor therapy)

assessment of therapy complications PROCEDURE

Ancillary studies

Arm I (higher-dose enzyme inhibitor therapy); Arm II (standard-dose enzyme inhibitor therapy); Arm III (standard-dose enzyme inhibitor therapy)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (higher-dose enzyme inhibitor therapy); Arm II (standard-dose enzyme inhibitor therapy); Arm III (standard-dose enzyme inhibitor therapy)

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed malignant solid tumor
• Refractory disease for which curative or palliative measures have failed or for which there is no known superior treatment
• No colorectal cancer or melanoma
• Measurable OR nonmeasurable disease
• Normotensive (blood pressure \[BP\] ≤ 140/90 mm Hg) meeting 1 of the following criteria:
• No more than 2 attempted measurement sessions for which the documented mean systolic BP is ≤ 140 mm Hg and the diastolic BP is ≤ 90 mm Hg
• At least 30 attempted measurement sessions for which the documented mean systolic BP is ≤ 135 mm HG and the diastolic BP is ≤ 85 mm Hg
• Brain metastases allowed provided the following criteria are met:
• Stable neurologic status for ≥ 2 weeks after completion of definitive local therapy (surgery or radiotherapy)
• No neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
• ECOG performance status 0-1
• Life expectancy \> 12 weeks
• Age ≥ 14 years OR weight ≥ 45 kilograms (pediatric patients)
• Not pregnant or nursing
• Negative pregnancy test

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

Sorafenib

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Michael Maitland

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 15, 2007
• First Posted: February 19, 2007
• Study Start: January 1, 2007
• Primary Completion: September 1, 2011
• Last Updated: February 24, 2014

Record last verified: 2011-10

Locations

US (1)