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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert L. DeJager, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Daiichi Sankyo Inc.

Authority:

United States: Federal Government

Study ID:

CDR0000067258

NCT ID:

NCT00004060

Start Date:

July 1999

Completion Date:

September 2000

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009