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A Phase I Study of Continuous Oral Administration of SCH 66336 and 5-Fluorouracil/Leucovorin (5FU/LV) in Patients With Advanced Cancer


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

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Trial Information

A Phase I Study of Continuous Oral Administration of SCH 66336 and 5-Fluorouracil/Leucovorin (5FU/LV) in Patients With Advanced Cancer


OBJECTIVES: I. Determine the safety, tolerability, maximum tolerated dose, and dose limiting
toxicity of oral SCH 66336 with fluorouracil and leucovorin calcium in patients with
advanced malignancy. II. Assess the multiple dose pharmacokinetics of oral SCH 66336 when
administered with fluorouracil and leucovorin calcium. III. Assess the pharmacokinetics of
fluorouracil when administered with oral SCH 66336. IV. Assess antitumor activity of oral
SCH 66336 with fluorouracil and leucovorin calcium in these patients.

OUTLINE: This is a dose escalation study of SCH 66336. Patients receive oral SCH 66336 twice
daily for 56 days. Patients receive leucovorin calcium IV over 1-2 minutes immediately
followed by fluorouracil IV over 1-2 minutes on days 1, 8, 15, 22, 29, and 36. Courses
repeat every 56 days in the absence of disease progression or unacceptable toxicity. Cohorts
of 3-6 patients receive escalating doses of SCH 66336. The maximum tolerated dose is defined
as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT)
during course 1, with at least 2 patients experiencing DLT at the next higher level.

PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven malignancy for which no curative therapy
exists At least 1 bidimensionally measurable lesion No acute or chronic leukemia or
multiple myeloma No active CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG-WHO 0-2 Life
expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than
1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic:
Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 3 times upper limit of
normal (ULN) (5 times ULN if elevations due to liver metastasis) Renal: Creatinine no
greater than 1.5 times ULN Cardiovascular: No prior or concurrent QTc interval
prolongation greater than 500 m/sec, unless approved by cardiology consult prior to study
Other: No malabsorption syndrome due to surgery, prior disease, or other unknown reason No
frequent vomiting or other medical condition that could interfere with oral medicine
intake (e.g., partial bowel obstruction, external biliary diversion) No concurrent
nonmalignant systemic disease making patient a poor risk for study No active uncontrolled
infection Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
and recovered No prior allogeneic, syngeneic, or autologous bone marrow transplantation No
prior peripheral blood stem cell transplantation No concurrent biologic therapy
Chemotherapy: No more than 2 prior chemotherapy regimens At least 4 weeks since prior
chemotherapy (6 weeks since mitomycin or nitrosoureas) and recovered No other concurrent
chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior
radiotherapy and recovered No prior wide field radiation (radiotherapy to at least 25% of
bone marrow, including pelvic irradiation) No concurrent radiotherapy Surgery: Prior major
gastrointestinal surgery allowed if recovered Other: At least 4 weeks since other prior
investigational therapy and recovered

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Leonard B. Saltz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067155

NCT ID:

NCT00003956

Start Date:

April 1999

Completion Date:

December 2009

Related Keywords:

  • Lymphoma
  • Unspecified Adult Solid Tumor, Protocol Specific
  • stage IV adult Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • unspecified adult solid tumor, protocol specific
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related primary CNS lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021