Valproic Acid-Based 2-Agent Oral Regimens for Patients With Advanced Solid Tumor
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00495872
First received: July 2, 2007
Last updated: October 16, 2012
Last verified: October 2012
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Purpose
The goal of this clinical research study is to find the highest tolerable dose of valproic acid in combination with either dasatinib, erlotinib hydrochloride, lapatinib, lenalidomide, sorafenib, or SU011248 (sunitinib malate) that can be given to patients with advanced cancer. The safety of each combination of the study drugs will be studied as well.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors |
Drug: Dasatinib Drug: Erlotinib Drug: Lapatinib Drug: Lenalidomide Drug: Sorafenib Drug: Sunitinib Drug: Valproic Acid |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-Arm Complete Phase 1 Trial of Valproic Acid-Based 2-Agent Oral Regimens for Patients With Advanced Solid Tumor |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Drug Information available for:
Valproic acid
Valproate sodium
Malic acid
Divalproex sodium
Erlotinib hydrochloride
Erlotinib
Lenalidomide
Lapatinib
Sorafenib
Dasatinib
Sunitinib malate
Lapatinib Ditosylate
Sorafenib tosylate
Sunitinib
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities [ Time Frame: At Day 28 (1 Cycle) ] [ Designated as safety issue: Yes ]
| Enrollment: | 204 |
| Study Start Date: | June 2007 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: VN
Valproic Acid + Sorafenib
|
Drug: Sorafenib
400 mg PO Daily for 21 Days Every 28 Days
Other Name: BAY 43-9006
Drug: Valproic Acid
40 mg/kg PO Daily for 7 Days, then 7 Days Off
Other Name: Depakene
|
|
Experimental: VS
Valproic Acid + Sunitinib
|
Drug: Sunitinib
25 mg PO Daily for 21 Days Every 28 Days
Other Names:
Drug: Valproic Acid
40 mg/kg PO Daily for 7 Days, then 7 Days Off
Other Name: Depakene
|
|
Experimental: VD
Valproic Acid + Dasatinib
|
Drug: Dasatinib
50 mg by mouth (PO) Twice Daily for 28 Days Every 28 Days
Other Names:
Drug: Valproic Acid
40 mg/kg PO Daily for 7 Days, then 7 Days Off
Other Name: Depakene
|
|
Experimental: VT
Valproic Acid + Erlotinib
|
Drug: Erlotinib
100 mg PO Daily for 28 Days Every 28 Days
Other Names:
Drug: Valproic Acid
40 mg/kg PO Daily for 7 Days, then 7 Days Off
Other Name: Depakene
|
|
Experimental: VL
Valproic Acid + Lapatinib
|
Drug: Lapatinib
1000 mg PO Daily for 28 Days Every 28 Days
Other Name: GW572016
Drug: Valproic Acid
40 mg/kg PO Daily for 7 Days, then 7 Days Off
Other Name: Depakene
|
|
Experimental: VR
Valproic Acid + Lenalidomide
|
Drug: Lenalidomide
15 mg PO Daily for 28 Days Every 28 Days
Other Names:
Drug: Valproic Acid
40 mg/kg PO Daily for 7 Days, then 7 Days Off
Other Name: Depakene
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have advanced solid tumor: they have either a disease where there is no established standard of care therapy or have failed one or more prior therapy. (for all treatment arms)
- Patients must have ECOG performance status < or = 2 (0-2). Patients </=10 years modified Lansky scale >/= 60. Patients >10 to 18 years Karnovsky scale >/= 60.(for all treatment arms)
- Patients must have normal organ and marrow function as defined below: Platelets > 50,000/uL; Creatinine clearance > 20mL/min (for all treatment arms); Total bilirubin < 5 mg/dL (except for Lapatinib arm); ALT </= 6X ULN for Lapatinib arm only;
- (cont. from above) Liver function criteria and dosing based on each individual drug: Valproic acid - if ALT >/= 6X ULN or T. Bili >/= 3, then dose should be decreased by 50%; Sorafenib - If Child Pugh class A or B, no dose adjustment; if Child Pugh class C, decrease dose by 50% (400 mg po daily max); Sunitinib - If ALT >/= 6X ULN or T. Bili >/= 3 , decrease dose by 25% (37.5 mg po daily max);
- (cont. from above) Erlotinib - If ALT > 6X ULN or T. Bili >/= 3 , decrease dose by 25% (100 mg po daily max); Lapatinib - If ALT > 3X ULN or T. Bili > 2X ULN, decrease dose by 60% (500-750 mg po daily max); Dasatinib - No dose adjustment needed; Lenalidomide - No dose adjustment needed.
- Patients or legal representative must be able to understand and be willing to sign an IRB-approved written informed consent document. (for all treatment arms)
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 30 days after the last dose. (for all treatment arms)
Exclusion Criteria:
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, symptomatic cardiac arrhythmia, active bleeding, active thrombosis, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of allergic reactions to the study drugs or their analogs.
- Failure to recover from any prior surgery within 4 weeks of study entry.
- Any treatment specific for tumor control within 3 weeks of study drugs; or within 2 weeks if cytotoxic agents were given weekly (within 6 weeks for nitrosoureas or mitomycin C), or within 4 half-lives for target agents with half lives and pharmacodynamic effects lasting less than 5 days (that include but are not limited to erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents); or failure to recover from the toxic effect of any therapy prior to study entry.
- Study agents cannot be obtained for any reason since this study does not provide free agents.
- Any prior history of hypertensive crisis or hypertensive encephalopathy.
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection) and symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment; and serious, non-healing wound, ulcer, or bone fracture.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495872
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Aung Naing, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00495872 History of Changes |
| Other Study ID Numbers: | 2007-0170 |
| Study First Received: | July 2, 2007 |
| Last Updated: | October 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Solid Tumors Advanced Cancer Dasatinib Erlotinib Lapatinib Lenalidomide |
Sorafenib Erlotinib Hydrochloride Sunitinib Malate Sunitinib Valproic Acid SU011248 |
Additional relevant MeSH terms:
|
Neoplasms Valproic Acid Erlotinib Sorafenib Dasatinib Lapatinib Lenalidomide Sunitinib Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Protein Kinase Inhibitors Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013