A Phase 1 Dose-Escalation Study of the Safety and Clinical Effects of ON 01910.Na in Combination With Either Irinotecan or Oxaliplatin in Patients With Hepatoma and Other Advanced Solid Tumors
18 Years
N/A
Both
Hepatoma, Advanced Solid Tumor
Trial Information
A Phase 1 Dose-Escalation Study of the Safety and Clinical Effects of ON 01910.Na in Combination With Either Irinotecan or Oxaliplatin in Patients With Hepatoma and Other Advanced Solid Tumors
This is an open-label, 2-arm, dose-escalation combination-therapy study in which patients
with hepatoma and other advanced malignancies will be assigned by the Investigator to dosing
with either irinotecan plus ON 01910.Na (Group A), or oxaliplatin plus ON 01910.Na (Group
B). Note: As of Amendment 2 of this protocol, treatment in the irinotecan arm of the study
(Group A) is closed to enrollment and patients will be enrolled only in Group B, the
oxaliplatin treatment arm. Patients will be enrolled in 1 of 4 Cohorts (4 sequential Cohorts
in Group B) of 3 patients each. Up to 6 additional patients will be tested at the MTD.
Inclusion Criteria:
- Male and female patients ≥18 years of age with histologically or cytologically
confirmed hepatoma and other solid tumors that are metastatic or progressive, for
whom no standard therapy holds curative potential and for whom irinotecan or
oxaliplatin are reasonable treatment options.
- Patients must have evaluable disease, either measurable on imaging or with
informative tumor marker(s).
- Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤2.
- Life expectancy >12 weeks.
- Any acute or chronic adverse effects of prior chemotherapy have resolved to
- Existing or planned central venous access with a 2-channel infusion catheter system.
- Laboratory values meet the following criteria: Absolute neutrophil count ≥1,500
cells/µL; Platelets ≥100,000 cells/µL; Total bilirubin ≤1.5 times the upper limit of
normal; AST (SGOT) ≤2.5 times the upper limit of normal; ALT (SGPT) ≤2.5 times the
upper limit of normal; Serum creatinine ≤1.5 mg/dL or a measured creatinine clearance
≥50 mL/min; Negative βhCG test in women of childbearing potential (defined as women
≤50 years of age or history of amenorrhea for ≤12 months prior to study entry).
- Patients with primary liver cancer or hepatic metastasis are eligible to enroll,
provided they meet the following: Total bilirubin is ≤2 mg/dL; AST and ALT are each
≤5 times the institutional upper limit of normal; Ascites, if present, is manageable
with diuretic agents alone.
- If there is a history of treated brain metastases, these must have been clinically
stable for ≥4 weeks prior to enrollment.
Exclusion Criteria:
- Women who are pregnant or lactating.
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study.
- Severe liver dysfunction (Child-Pugh Class C or uncompensated Class B with persistent
encephalopathy, persistent ascites, or prothrombin time >1.5 times the upper limit of
normal) is present.
- Patients with a history of esophageal bleeding are excluded unless arices have been
sclerosed or banded and bleeding episodes have not occurred during the prior 6
months.
- Contraindications, including known hypersensitivity, to the assigned chemotherapy
agent (i.e., irinotecan or oxaliplatin).
- Prior receipt of ON 01910.Na or prior participation in this protocol.
- Use of any investigational agents within 4 weeks of study enrollment.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection or psychiatric illness/social situations that would limit compliance with
study requirements, as determined by the Investigator.
- Patients with ascites requiring active medical management including paracentesis,
peripheral bilateral edema or hyponatremia (defined as serum sodium value of <134
Meq/L).
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
maximum tolerated dose
Outcome Time Frame:
6 - 12 months
Safety Issue:
Yes
Principal Investigator
Takao Ohnuma, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mount Sinai School of Medicine
Authority:
United States: Food and Drug Administration
Study ID:
Onconova 04-08
NCT ID:
NCT00861783
Start Date:
June 2008
Completion Date:
July 2011
Related Keywords:
- Hepatoma
- Advanced Solid Tumor
- oxaliplatin
- diaminocyclohexane oxalatoplatinum
- oxalatoplatin
- oxalatoplatinum
- Eloxatin
- Liver Neoplasms
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| Mount Sinai Medical Center | New York, New York 10029 |
