SU6668 in Treating Patients With Advanced Solid Tumors

January 22, 2013 updated by: National Cancer Institute (NCI)

A Phase I Surrogate Endpoint Trial of SU6668 in Patients With Incurable Solid Tumors

Phase I trial to study the effectiveness of SU6668 in treating patients who have advanced solid tumors. SU6668 may stop the growth of solid tumors by stopping blood flow to the tumor

Study Overview

Detailed Description

OBJECTIVES:

I. Determine the optimal biologically effective dose of SU6668 in patients with advanced solid tumors.

II. Assess the safety and tolerability of this therapy in these patients. III. Determine the pharmacokinetic profile and interpatient pharmacologic variability of this therapy in these patients.

IV. Determine the extent, frequency, and duration of any tumor responses in patients treated with this therapy.

V. Determine a recommended phase II dose of SU6668 for future clinical studies.

OUTLINE: This is a dose-escalation study.

Patients receive oral SU6668 twice daily on days 1-28. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression of 100% or more.

Cohorts of at least 6 patients receive escalating doses of SU6668 until the optimal biologically effective dose (OBD) is determined. Once the OBD is reached, dose escalation continues until the maximum tolerated dose (MTD) is determined (if possible). The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed advanced solid tumor for which no standard therapy exists
  • At least 1 measurable tumor lesion (at least 2 cm) not previously irradiated
  • No history of brain metastases

    • Negative brain CT/MRI required for patients with signs and symptoms suspicious for brain metastases
  • Performance status - ECOG 0-1
  • WBC greater than 3,000/mm^3
  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 10 g/dL
  • No history of bleeding diathesis
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT less than 2.5 times ULN
  • Creatinine less than 1.5 mg/dL
  • Creatinine clearance greater than 60 mL/min
  • No concurrent uncontrolled medical or psychiatric disorders
  • No severe iodine allergy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • At least 30 days since prior over-the-counter, anticancer biologic agents (e.g., shark cartilage)
  • No concurrent over-the-counter, anticancer biologic agents (e.g., shark cartilage)
  • At least 3 weeks since prior cytotoxic or cytostatic agents (6 weeks for nitrosoureas or mitomycin)
  • Patients with ECOG performance status 0:

    • Any number of prior chemotherapy regimens allowed
  • Patients with ECOG performance status 1:

    • No more than 3 prior chemotherapy regimens for metastatic or recurrent disease
    • The same drug given on a different schedule does not count as a different regimen
    • Prior adjuvant chemotherapy for non-metastatic disease or as part of a concurrent chemoradiotherapy protocol is allowed but does not count as part of the 3-regimen limit
  • See Disease Characteristics
  • See Chemotherapy
  • At least 3 weeks since prior radiotherapy to nonindicator lesions
  • No concurrent radiotherapy
  • At least 24 hours since prior minor surgery (e.g., central venous catheter placement)
  • At least 4 weeks since prior major surgery (e.g., laparotomy, thoracotomy, or craniotomy)
  • At least 30 days since prior anticancer herbal remedies
  • At least 30 days since prior investigational agents
  • No concurrent anticancer herbal remedies
  • No other concurrent investigational or anticancer medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (orantinib)

Patients receive oral SU6668 twice daily on days 1-28. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression of 100% or more.

Cohorts of at least 6 patients receive escalating doses of SU6668 until the OBD is determined. Once the OBD is reached, dose escalation continues until the maximum tolerated dose (MTD) is determined (if possible). The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Correlative studies
Correlative studies
Other Names:
  • pharmacological studies
Given orally
Other Names:
  • SU006668
  • SU6668
  • Sugen SU6668
  • TSU 68

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events, as defined by the Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) term and body system, graded according to the National Cancer Institute Common Toxicity Criteria v2.0
Time Frame: Up to 2 years
Up to 2 years
Maximally tolerated dose of orantinib, graded according to the NCI CTC v2.0
Time Frame: Up to 4 weeks
Up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response, assessed using the Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: Up to 2 years
Up to 2 years
Angiogenic surrogate measures in terms of change in cytokines over time
Time Frame: Days 8, 15, and 22
A mixed-effects analysis of variance (ANOVA) model will be used, and a fixed-effects model in which the same polynomial is fit for each patient will be used.
Days 8, 15, and 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Roy Herbst, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (Actual)

July 1, 2003

Study Registration Dates

First Submitted

September 13, 2001

First Submitted That Met QC Criteria

October 20, 2003

First Posted (Estimate)

October 21, 2003

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • NCI-2012-02412
  • U01CA062461 (U.S. NIH Grant/Contract)
  • ID00-184
  • CDR0000068900 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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