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Phase I Trial of R115777 (NSA 702818) in Advanced Malignant Solid Tumors


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

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Trial Information

Phase I Trial of R115777 (NSA 702818) in Advanced Malignant Solid Tumors


OBJECTIVES:

- Determine the maximum tolerated dose of R115777 in patients with advanced malignant
solid tumors.

- Assess the toxicity of this drug in these patients.

- Determine, preliminarily, the efficacy of this drug in these patients.

- Determine the potential predictors of response in patients treated with drug.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive oral R115777 twice daily on weeks 1 and 3. Treatment repeats every 28 days
in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3
or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A minimum of 20 patients will be accrued for this study within 12 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed malignant tumors deemed to be incurable or refractory to
therapy

- Advanced, recurrent, or metastatic disease

- Previously treated with at least 1 chemotherapy regimen

- Brain metastases allowed if asymptomatic and controlled (e.g., after prior surgical
resection or radiotherapy/radiosurgery) and not on steroids or anticonvulsants

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,500/mm3

- Absolute granulocyte count at least 1,500/mm3

- Platelet count at least 75,000/mm3

Hepatic:

- Bilirubin no greater than 2.5 times upper limit of normal (ULN)

- SGOT no greater than 2.5 times ULN

Renal:

- Creatinine clearance at least 60 mL/min OR

- Creatinine no greater than 1.6 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent biologic therapy

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea)

Endocrine therapy:

- See Disease Characteristics

- No concurrent hormonal therapy

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy and recovered

- No prior radiotherapy to a field containing a measurable target lesion unless there
is evidence of progression or a new lesion is present

- No concurrent radiotherapy to measurable lesions

Surgery:

- See Disease Characteristics

- At least 3 weeks since prior major surgery and recovered

Other:

- At least 2 weeks since prior proton pump inhibitors (e.g., omeprazole)

- Concurrent H2 blockers (e.g., cimetidine or related drugs) or antacids are allowed if
there is an interval of at least 2 hours between H2 blocker/antacid intake and
R115777 dosing

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Primo N. Lara, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis

Authority:

United States: Federal Government

Study ID:

CDR0000068963

NCT ID:

NCT00025454

Start Date:

August 2001

Completion Date:

July 2008

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010
City of Hope Medical GroupPasadena, California  91105