SU6668 in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00024206
First received: September 13, 2001
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: orantinib
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Maximally tolerated dose of orantinib, graded according to the NCI CTC v2.0 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response, assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Angiogenic surrogate measures in terms of change in cytokines over time [ Time Frame: Days 8, 15, and 22 ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: July 2001
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: orantinib
Given orally
Other Names:
  • SU006668
  • SU6668
  • Sugen SU6668
  • TSU 68
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

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.

  Eligibility

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

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

Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Roy Herbst M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00024206     History of Changes
Other Study ID Numbers: NCI-2012-02412, ID00-184, U01CA062461, CDR0000068900
Study First Received: September 13, 2001
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014