- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003358
Cisplatin and Gemcitabine in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Phase I Trial Intraperitoneal Cisplatin With Intraperitoneal Gemcitabine in Patients With Epithelial Ovarian Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of cisplatin plus gemcitabine in treating patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Determine the maximum tolerated dose of intraperitoneal (IP) gemcitabine given in combination with IP cisplatin in patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer. II. Determine the safety of this regimen in this patient population. III. Determine the pharmacokinetics of IP gemcitabine administered with IP cisplatin.
OUTLINE: This is a dose escalation study of gemcitabine. Patients receive intraperitoneal cisplatin on day 1 plus intraperitoneal gemcitabine on days 1, 8, and 15. No treatment will be given on day 22. Courses are repeated every 4 weeks. Patients receive up to 4 courses of therapy. Dose escalation of gemcitabine continues in cohorts of 3 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity (DLT). Patients are followed every 3 months for 2 years, then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued for this study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically documented epithelial ovarian carcinoma or fallopian tube cancer or primary peritoneal cancer following initial cytoreductive surgery and chemotherapy with at least one cisplatin based chemotherapy regimen Must have undergone a second assessment procedure (laparoscopy or laparotomy) within 8 weeks of protocol entry, and have confirmation of residual disease no greater than 1.0 cm at the end of the procedure
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 3 times upper limit of normal (ULN) SGOT less than 3 times ULN Alkaline phosphatase less than 3 times ULN Renal: Creatinine less than 1.6 mg/dL Creatinine clearance at least 50 mL/min Other: Must have a functioning implanted subcutaneous intraperitoneal catheter No neuropathy of grade III or greater from prior chemotherapy No contraindication to intraperitoneal therapy e.g., intraabdominal infection or widespread adhesions
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Adnexal Diseases
- Fallopian Tube Diseases
- Fallopian Tube Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Cisplatin
Other Study ID Numbers
- 97-129
- MSKCC-97129
- NCI-H98-0016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Cancer
-
Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
-
Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Health Science Center of Xi'an Jiaotong UniversityRecruitingOvarian Cancer | Cancer of the Ovary | Ovarian Neoplasm | Ovary Cancer | Neoplasms, Ovarian | Ovary Neoplasms | Ovary Neoplasm | Cancer of Ovary | Cancer, Ovarian | Ovarian Cancers | Neoplasm, Ovarian | Neoplasm, Ovary | Neoplasms, Ovary | Cancer, Ovarian Stromal | Cancers, Ovary | Ovary Cancers | Cancers, OvarianChina
Clinical Trials on chemotherapy
-
University of WashingtonNational Cancer Institute (NCI)CompletedAdult Acute Myeloid Leukemia | Adult Myelodysplastic SyndromeUnited States
-
Cancer Institute and Hospital, Chinese Academy...Unknown
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingColorectal Adenocarcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Colorectal Carcinoma Metastatic in the LungUnited States, Canada
-
International Atomic Energy AgencyCompletedNon Small Cell Lung CancerChile, China, Croatia, Egypt, India, Malaysia, Malta, Morocco, Pakistan, Panama, Peru, South Africa, Tunisia
-
Ping LiangNot yet recruitingChemotherapy | Liver Metastases | Colorectal Carcinoma
-
Second Affiliated Hospital, School of Medicine,...UnknownUnresectable Gastric Cancer | Successful Conversion Rate of OperationChina
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Yantai Yuhuangding HospitalRecruiting
-
Shenzhen SiBiono GeneTech Co.,LtdUnknown
-
Ruijin HospitalNot yet recruitingGastric Cancer | Neoadjuvant ChemotherapyChina