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Study Summary
No. 2004-0568:.......Breast; Cervix; Colon; Colorectal; Endometrial; Esophageal; Gallbladder; Gastric; Gastrointestinal; Genitourinary; Gynecology; Head And Neck; Kidney; Liver; Lung; Lymphoma; Melanoma; Pancreas; Prostate; Rectum; Sarcoma; Small Bowel; Testis; Unknown Primary; Uterus......Apostolia M. Tsimberidou......Investigational Cancer Therapeutics
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Study Summary Title
Study Summary
Number:
2004-0568
Study Title:A Phase I Study Dose Escalation Clinical Study Of Hepatic Intraarterial Cisplatin, In Combination With Systemic Intravenous Liposomal Doxorubicin Administered Every Four Weeks to Patients With Advanced Cancer And Dominant Liver Involvement
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Physician New Patient Referral
Name:Apostolia M. TsimberidouPatients 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:713-792-4259
Contact us about clinical trials
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General Information
Disease Group:Breast
Cervix
Colon
Colorectal
Endometrial
Esophageal
Gallbladder
Gastric
Gastrointestinal
Genitourinary
Gynecology
Head And Neck
Kidney
Liver
Lung
Lymphoma
Melanoma
Pancreas
Prostate
Rectum
Sarcoma
Small Bowel
Testis
Unknown Primary
Uterus
Supported By:N/A
Phase of Study:Phase IReturn
Visit:
Patients will return to MDACC for a clinical evaluation on a monthly basis
Treatment
Agents:
Cisplatin
Liposomal Doxorubicin
Home Care:The initial or loading doses of liposomal doxorubicin will be given in the
clinic. Subsequent doses may be given at home.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Patients will be admitted for approximately 5-7 days until recovery from all
immediate treatment related toxicities
Description/
Intervention:
The goal of this clinical research study is find the highest safe dose of
cisplatin that can be given with liposomal doxorubicin in the treatment of
advanced cancer involving the liver.
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Study Objectives / Outcomes
PRIMARY
  • To determine the toxicity and safety of a monthly cytotoxic regimen combining intraarterial hepatic cisplatin with systemic intravenous liposomal doxorubicin in patients with cancer metastatic to the liver.

SECONDARY
  • To document in a descriptive fashion the antitumor efficacy of monthly hepatic intraarterial cisplatin in combination with systemic liposomal doxorubicin.
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Study Status Information
Study Activation / Registration Date:03/02/2005
IRB Review and Approval Date:10/20/2004
Study Type:Therapeutic
Recruitment Status:Terminated
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) Patients with Histologically confirmed diagnosis of malignancy and liver involvement as dominant site of metastasis (over 50% of all tumor burden).

2) Pediatric patients eligible at the discretion of the primary investigator.

3) Performance Status Equivalent or Grater than 60% in the Karnofski's Performance scale (Requires occasional assistance but is able to care for own needs).

4) Adequate Renal Function (Serum CRE </= 1.5 mg/dL) or calculated Creatinine Clearance >/= 50 ml/min (Cockroft Formula).

5) Adequate Hepatic Function (Total Bilirubin </= 1.5 mg/dL or ALT </= 5 times upper normal reference value).

6) Adequate Bone Marrow Function (ANC >/= 1.5 cells/uL; PLT >/= 100,000 cells/uL).

7) At least three weeks from previous cytotoxic chemotherapy before day 1 of HAI infusion. After targeted or biologic therapy there should be 5 half-lives or three weeks, whichever is shorter.

8) All Females in Childbearing Age MUST have a negative urine or serum HCG test unless prior histerectomy or menopause (defined as age above 55 and six months without menstrual activity).

9) Ability to fully read, comprehend, and sign informed consent forms. In pediatric patients, the informed consent forms will be signed by a parent or legal guardian.

10) Patients with germ cell tumors and lymphoma MUST have had documented progression of disease prior to enrollment.

Exclusion Criteria:1) Clinical or radiographic evidence of Ascites.

2) Pregnant females.

3) Hypersensitivity to platinum compounds or anthracyclins.

4) Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.

5) Jaundice. (Bilirubin > 1.5 mg/dL).

6) Bleeding Diathesis.(Prothrombin time > 20 secs or INR > 2.0).

7) Portal vein thrombosis.

8) Grade 2 Peripheral Neuropathy (CTC V3.0: Sensory alteration interfering with function but not interfering with ADL)

9) Medical History or Clinical Evidence of Congestive Heart Failure.

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Links
Registration Number: NCT00507962
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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