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Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: December 3, 2009   History of Changes
Sponsor: Memorial Sloan-Kettering Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003345
  Purpose

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 II trial to study the effectiveness of combining cisplatin and irinotecan in treating patients who have ovarian, fallopian tube, or peritoneal cancer.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: cisplatin
Drug: irinotecan hydrochloride
Phase II

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Trial of Cisplatin and Irinotecan in Patients With Suboptimally Debulked, Incompletely Responding Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 35
Study Start Date: October 1997
Primary Completion Date: October 2001 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Evaluate the antitumor effect of weekly cisplatin and irinotecan in patients with suboptimally debulked ovarian, fallopian tube, or peritoneal cancer and persistently elevated serum values of CA125 after 3 courses of standard therapy with paclitaxel and either carboplatin or cisplatin. II. Evaluate the toxicity, both qualitative and quantitative, of this regimen in this patient population. III. Evaluate the quality of life of these patients.

OUTLINE: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 90 minutes. Treatment is administered weekly for 4 weeks (days 1, 8, 15, and 22) followed by 2 weeks of rest. Patients receive at least 3 courses (18 weeks) of therapy in the absence of disease progression or unacceptable toxicity. If patients demonstrate complete response to treatment, they are encouraged to undergo second-look laparoscopy or laparotomy. Quality of life is assessed before treatment, after the first course, and then after every 2 courses of therapy. Patients are followed 30 days after the last treatment and then for survival.

PROJECTED ACCRUAL: There will be 12-35 patients accrued into this study over 18-24 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed epithelial carcinoma of the ovary, fallopian tube, or peritoneum At least 3 prior courses of standard platinum-paclitaxel regimen Patients with taxane allergy may enter this study after 3 courses of platinum based treatment CA125 at least 35 measured within 30 days of commencement of treatment Measurable disease not required No CNS metastases, carcinomatous meningitis or interstitial pulmonary fibrosis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Calcium less than 12.0 mg/dL Cardiovascular: No unstable angina No New York Heart Association grade III or IV cardiac disease Pulmonary: See Disease Characteristics Other: No active or uncontrolled infection No history of seizures No known Gilbert's Disease No medical or psychiatric conditions that makes patient a poor risk for participation in this study Not pregnant or lactating Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior irinotecan or topotecan Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the pelvis Surgery: At least 4 weeks since prior surgery and recovered Other: No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003345

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: David R. Spriggs, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000066322, MSKCC-97121, NCI-H98-0013
Study First Received: November 1, 1999
Last Updated: December 3, 2009
ClinicalTrials.gov Identifier: NCT00003345     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Irinotecan
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Cisplatin
Therapeutic Uses
Peritoneal Diseases
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Abdominal Neoplasms
Fallopian Tube Neoplasms
Camptothecin
Pharmacologic Actions
Adnexal Diseases
Fallopian Tube Diseases
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Peritoneal Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on March 18, 2010