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Study Summary
No. 2007-0030:.......Advanced Cancers; Ovary; Solid Tumors......Gerald Falchook......Investigational Cancer Therapeutics
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Study Summary Title
Study Summary
Number:
2007-0030
Study Title:Phase I/II trial of sequential azacitidine and valproic acid plus carboplatin in the treatment of patients with advanced malignancies and platinum resistant epithelial ovarian cancer
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Physician New Patient Referral
Name:Gerald FalchookPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Investigational Cancer TherapeuticsReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-1930
Contact us about clinical trials
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General Information
Disease Group:Advanced Cancers
Ovary
Solid Tumors
Supported By:Pharmion
Phase of Study:Phase I/Phase IIReturn
Visit:
once every 4 weeks
Treatment
Agents:
Azacytidine
Carboplatin
Valproic Acid
Home Care:NA
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
NA
Description/
Intervention:
The goal of this clinical research study is to find out if giving azacitidine
with valproic acid plus carboplatin can help control advanced cancer. The
safety of this treatment will be studied as well. Researchers will also collect
some extra blood samples for molecular marker studies (studies that may help
researchers predict how participants respond to the combined therapy).

There are 2 phases in this study: a Phase 1 portion to find acceptable doses of
the study drug combination, and a Phase 2 portion to study the response rates
to the treatment schedule.
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Study Objectives / Outcomes
Primary Objectives

1. To determine acceptable dosages of valproic acid and carboplatin in a regimen of sequential azacitidine and valproic acid plus carboplatin in the treatment of patients with advanced solid tumor during the phase 1 part.

2. To assess objective response rates in platinum resistant epithelial ovarian cancer patients treated with sequential azacitidine and valproic acid plus carboplatin during the phase 2 part.

3. To determine whether DNA methylation, and histone H3 and H4 acetylation of tumor tissue and peripheral blood monocytes are able to predict objective responses.

Secondary Objectives

1. To describe toxicity profile.

2. To assess progression-free survival.

3. To assess overall survival.
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Study Status Information
Study Activation / Registration Date:08/21/2007
IRB Review and Approval Date:08/21/2007
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Closed
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patient has histologically or cytologically confirmed diagnosis of advanced solid tumor (that has progressed following standard therapy or for whom, in the opinion of the investigator, no standard effective therapy is available) during the phase I study. Only patients who have platinum resistant epithelial carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma are enrolled onto the phase II study. According to standard GOG criteria platinum resistant is defined to have had a disease-free interval of shorter than 6 months following platinum treatment.

2) Patient has measurable or evaluable disease by radiological imaging techniques with documented progression within 1 month before study entry or disease that has not responded to treatment. (Pleural effusions, ascites, osseous metastasis, elevation of tumor marker and lesions located in previously irradiated areas are not considered measurable).

3) Patient is willing to comply with study procedures to have blood collections for correlative studies.

4) Patient has an ECOG performance status of 0-2.

5) Patient must be informed of the investigational nature of this study and must sign and give written IRB approved informed consent in accordance with institutional guidelines.

6) If patient is of child-bearing potential, she or he has agreed to practice an effective method of birth control during the study and up to 3 months after the last treatment.

7) Patient has adequate liver and renal function: serum albumin =/>3.0 g/dL; serum bilirubin =/<2.0 mg/dL; ALT=/<3x upper limit of normal (uln); and serum creatinine =/< 2.0 mg/dL or a calculated creatinine clearance of at least 40 ml/min.

8) Patient has adequate bone marrow reserve. ANC=/>1,500/ul, Platelet count =/>100,000/ul, and Hemoglobin =/>9.0g/dL.

Exclusion Criteria:1) Any concurrent chemotherapy.

2) Underlying medical condition that might be aggravated by treatment or that cannot be controlled, such as active uncontrolled serious infection and cardiac dysfunction.

3) Medical and psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk.

4) Known hypersensitivity to azacitidine, valproic acid, carboplatin or their analogs.

5) Failure to recover from any prior surgery within 4 weeks of study entry.

6) Pregnant or lactating.

7) Any treatment specific for tumor control within 3 weeks of dosing with study drugs (within 2 weeks if given weekly or within 6 weeks for nitrosoureas or mitomycin C) or failure to recover from the toxic effect of any of these therapies prior to study entry. Any investigational drug within 30 days of first day of dosing.

8) Any signs of intestinal obstruction interfering with nutrition or oral intake.

9) History of CNS metastasis unless the patient has had surgery or radiation, and does not require oral or intravenous corticosteroids or anticonvulsants.

10) Advanced malignant hepatic tumors that are defined as the total hepatic metastases more than 25% of hepatic parenchyma.

11) History of high dose chemotherapy for ovarian cancer in phase II study. High dose chemotherapy is defined as the intensity and/or the density of a chemotherapeutic agent that are beyond standard of care for ovarian cancer treatment.

12) History of prior malignancy except for adequately treated carcinoma in situ of the uterine cervix, basal cell or squamous cell skin cancer, or other cancer for which the patient has been disease free for at least two years in phase II study.

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Links
Registration Number: NCT00529022
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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