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SU6668 in Treating Patients With Advanced Solid Tumors
This study has been completed.
First Received: September 13, 2001   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00024206
  Purpose

RATIONALE: SU6668 may stop the growth of solid tumors by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of SU6668 in treating patients who have advanced solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: SU6668
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Surrogate Endpoint Trial of SU6668 in Patients With Incurable Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 2001
Detailed Description:

OBJECTIVES:

  • Determine the optimal biologically effective dose of SU6668 in patients with advanced solid tumors.
  • Assess the safety and tolerability of this therapy in these patients.
  • Determine the pharmacokinetic profile and interpatient pharmacologic variability of this therapy in these patients.
  • Determine the extent, frequency, and duration of any tumor responses in patients treated with this therapy.
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC greater than 3,000/mm3
  • Absolute neutrophil count greater than 1,500/mm3
  • Platelet count greater than 100,000/mm3
  • Hemoglobin greater than 10 g/dL
  • No history of bleeding diathesis

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT less than 2.5 times ULN

Renal:

  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Other:

  • No concurrent uncontrolled medical or psychiatric disorders
  • No severe iodine allergy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • 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)

Chemotherapy:

  • 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 nonmetastatic disease or as part of a concurrent chemoradiotherapy protocol is allowed but does not count as part of the 3-regimen limit

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • See Chemotherapy
  • At least 3 weeks since prior radiotherapy to nonindicator lesions
  • No concurrent radiotherapy

Surgery:

  • 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)

Other:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024206

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Roy S. Herbst, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068900, MDA-ID-00184, NCI-1017
Study First Received: September 13, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00024206     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on July 02, 2009