Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00217555
• Other study ID #: PSOC 1901
• Secondary ID: PSOC-1901GSK-PSO
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2005
• Last updated: September 20, 2010
• Start date: July 2002

Study information

• Verified date: September 2010
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Cavity Cancer
• Peritoneal Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• topotecan hydrochloride

Locations

Country	Name	City	State
United States	University of Washington School of Medicine	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Sou — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity			Yes
Primary	Response rate			No
Primary	Quality of life			No
Secondary	Progression-free survival			No
Secondary	Overall survival			No