Brief Title
Chemotherapy in Treating Patients With Recurrent, Metastatic, or Unresectable Ovarian, Fallopian Tube, or Peritoneal Cancer
Official Title
A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Advanced Ovarian, Tubal, or Peritoneal Cancer Refractory to Platinum, Taxane and Topotecan
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have
recurrent, metastatic, or unresectable ovarian, fallopian tube, or peritoneal cancer.
Detailed Description
OBJECTIVES: I. Determine the antitumor activity of DX-8951f in patients with recurrent,
metastatic, or unresectable ovarian, tubal, or peritoneal carcinoma that is refractory to
platinum, taxane, and topotecan. II. Evaluate the quantitative and qualitative toxic effects
of this regimen in these patients. III. Evaluate the pharmacokinetics of this regimen in
these patients.
OUTLINE: Patients are stratified by prior chemotherapy (minimally pretreated vs heavily
pretreated). Patients receive intravenous DX-8951f over 30 minutes daily for 5 days. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients
are followed every 3 months until death.
PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.
Study Phase
Phase 2
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
exatecan mesylate
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
July 1999
Completion Date
September 2000
Primary Completion Date
September 2000
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed recurrent, metastatic, or unresectable
ovarian, tubal, or peritoneal carcinoma that is refractory to platinum, taxane, and
topotecan Must have received at least 1 prior chemotherapy regimen Resistance to platinum,
taxane, and topotecan is defined as the following: Progressive disease while on
chemotherapy OR Relapse within six months of completing chemotherapy OR Failure to achieve
complete response after six courses of chemotherapy No recurrent or metastatic disease
amenable to attempted curative therapy with surgery and/or radiotherapy Measurable disease
No brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater
than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal:
Creatinine no greater than 1.5 mg/dL Cardiovascular: No active congestive heart failure No
uncontrolled angina No myocardial infarction within past 6 months Other: Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception No
concurrent serious infection No psychiatric disorder or mental disability No other
malignancy within past 5 years, except: Nonmelanomatous skin cancer Carcinoma in situ of
the cervix No other life threatening illness No history of camptothecin derivative allergy
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy:
See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for
nitrosoureas or mitomycin) No other concurrent chemotherapy Endocrine therapy: Not
specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior
radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics At least 4
weeks since prior surgery No concurrent surgery Other: At least 4 weeks since other prior
investigational drugs No other concurrent investigational drugs and for 4 weeks after study
treatment
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Robert L. DeJager, MD, FACP, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00004060
Organization ID
CDR0000067258
Secondary IDs
DAIICHI-8951A-PRT008
Responsible Party
Sponsor
Study Sponsor
Daiichi Sankyo, Inc.
Study Sponsor
Robert L. DeJager, MD, FACP, Study Chair, Daiichi Sankyo, Inc.
Verification Date
May 2012