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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.   Last updated on July 23, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Official Title  Phase II Trial for the Treatment of Recurrent or Persistent Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer With Gemcitabine and Topotecan
Brief Summary

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.

Detailed Description

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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Open Label
Primary Outcome Measure  Toxicity [ Designated as safety issue: Yes ]
Response rate [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]
Secondary Outcome Measure  Progression-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Condition  Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Intervention  Drug: gemcitabine hydrochloride
Drug: topotecan hydrochloride
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  July 2002
Completion Date
Eligibility Criteria 

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
Gender Female
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00217555
Organization ID CDR0000441309
Secondary IDs †† PSOC-1901, GSK-PSOC-1901, PSOC-IRB-5320, LILLY-PSOC-1901
Study Sponsor  Puget Sound Oncology Consortium at Fred Hutchinson Cancer Research Center
Collaborators †† National Cancer Institute (NCI)
Investigators 
Principal Investigator:     Barbara A. Goff, MD     University of Washington    
Information Provided By National Cancer Institute (NCI)
Verification Date March 2006
First Received Date  September 20, 2005
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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