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Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
This study is ongoing, but not recruiting participants.
Study NCT00217555   Information provided by National Cancer Institute (NCI)
First Received: September 20, 2005   Last Updated: November 27, 2008   History of Changes

September 20, 2005
November 27, 2008
July 2002
 
  • Toxicity [ Designated as safety issue: Yes ]
  • Response rate [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Toxicity
  • Response rate
  • Quality of life
Complete list of historical versions of study NCT00217555 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival
  • Overall survival
 
Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Phase II Trial for the Treatment of Recurrent or Persistent Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer With Gemcitabine and Topotecan

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with topotecan works in treating patients with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cavity cancer.

OBJECTIVES:

Primary

  • Determine the nature and degree of toxicity of gemcitabine and topotecan in patients with recurrent or persistent platinum-refractory ovarian, fallopian tube, or primary peritoneal cavity cancer.
  • Determine the response rate in patients treated with this regimen.
  • Determine the quality of life of patients treated with this regimen.

Secondary

  • Determine the duration of progression-free survival and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes and topotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond documentation of CR.

Quality of life is assessed at baseline, on day 1 of courses 2, 4, and 6, and then at 1 year.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 36-45 patients will be accrued for this study within 3 years.

Phase II
Interventional
Treatment, Open Label
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Drug: gemcitabine hydrochloride
  • Drug: topotecan hydrochloride
 
Goff BA, Holmberg LA, Veljovich D, Kurland BF; Puget Sound Oncology Consortium. Treatment of recurrent or persistent platinum-refractory ovarian, fallopian tube or primary peritoneal cancer with gemcitabine and topotecan: a phase II trial of the Puget Sound Oncology Consortium. Gynecol Oncol. 2008 Aug;110(2):146-51. Epub 2008 Jun 6.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Diagnosis of ovarian, fallopian tube, or primary peritoneal cavity cancer
  • Recurrent or persistent platinum-refractory disease, as defined by 1 of the following:

    • Progressive disease while on a platinum compound
    • Persistent clinically measurable disease with best response as stable disease at the completion of ≥ 6 courses of therapy
    • Recurrent disease within 6 months after completion of therapy
  • Measurable or evaluable disease

    • Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests)
    • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI, OR ≥ 10 mm by spiral CT scan

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-3

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance > 50 mL/min

Other

  • No clinically significant infection
  • No other severe medical condition that would preclude study treatment
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • Prior gemcitabine or topotecan allowed provided disease is not refractory to either drug
  • At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 3 weeks since prior radiotherapy and recovered

Surgery

  • Recovered from recent prior surgery
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00217555
 
CDR0000441309, PSOC-1901, GSK-PSOC-1901, PSOC-IRB-5320, LILLY-PSOC-1901
Puget Sound Oncology Consortium at Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Barbara A. Goff, MD University of Washington
National Cancer Institute (NCI)
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP