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


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Up to 2 years

Safety Issue:

Yes

Principal Investigator

Roy Herbst

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02412

NCT ID:

NCT00024206

Start Date:

July 2001

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms

Name

Location

M D Anderson Cancer CenterHouston, Texas  77030