Interaction Study of Rapamycin and Sunitinib in Patients With Advanced Cancers

NCT00583063 | Completed Early Phase 1 DMC

• 1 other identifier: 15328B
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the pharmacokinetic interactions between rapamycin and sunitinib in patients with advanced solid tumors.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic interactions

  4 weeks

Secondary Outcomes (2)

• Toxicity of the combined drug regimen

  4 weeks

• Response to drug regimen

  8 weeks

Study Arms (2)

A

EXPERIMENTAL

Sunitinib taken by mouth every day. Rapamycin (taken by mouth) will be started on Day 15 and then taken every day. Drugs can be taken until disease progression.

Drug: sunitinib; Drug: rapamycin

B

EXPERIMENTAL

Rapamycin taken by mouth every day. Sunitinib (taken by mouth) will be started on Day 15 and then taken every day. Drugs can be taken until disease progression.

Drug: sunitinib; Drug: rapamycin

Interventions

sunitinib DRUG

25 mg daily (oral dosing)

Also known as: Sutent

A; B

rapamycin DRUG

4 mg daily (oral dosing)

Also known as: Rapamune

A; B

Eligibility Criteria

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

You may qualify if:

• Metastatic or unresectable cancer for which standard treatments do not exist or are no longer effective or cancers where evidence of efficacy of single agent sunitinib or single agent mTOR inhibitor has been demonstrated
• Measurable or non-measurable disease.
• No prior treatments for 4 weeks before starting study
• No ongoing toxicities from previous treatments
• years or older
• Performance status 2 or better
• Life expectancy of at least 3 months.
• Normal organ and marrow function as defined below:
• No transfusions of packed red blood cells within 1 week of starting treatment. A hemoglobin of 9.0 g/dL or greater is recommended. Patients should not be transfused for protocol participation.
• Leukocytes greater than or equal to 3,000/μL
• Absolute neutrophil count greater than or equal to 1,500/μL
• Platelets greater than or equal to 100,000/μL
• Total bilirubin less than or equal to 1.5 x ULN
• AST and ALT less than or equal to 2.5x ULN (less than or equal to 5x ULN if liver function abnormalities are due to underlying disease)
• Creatinine within normal institutional limits OR

You may not qualify if:

• Prior treatments within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of entering the study or those who have not recovered from adverse events due prior treatments
• Current treatment with other investigational agents.
• Prior therapy with a VEGFR or mTOR inhibitor
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to rapamycin or sunitinib.
• QTc prolongation (QTc interval equal to or greater than 500 msec) or other significant ECG abnormalities
• Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with any of the following conditions are excluded:
• Serious or non-healing wound, ulcer, or bone fracture.
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment.
• Known active infection
• Major surgery or radiation therapy within 4 weeks of starting the study treatment.
• NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment.
• History of CVA or transient ischemic attack within 12 months prior to study entry.
• History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to study entry.
• History of pulmonary embolism within the past 12 months.

Sponsors & Collaborators

• University of Chicago: lead
• Pfizer: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

Sunitinib; Sirolimus

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Macrolides; Lactones; Organic Chemicals

Study Officials

• Ezra Cohen, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: October 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 12, 2013

Record last verified: 2011-03

Locations

US (1)