Brief Title
Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Official Title
A Randomized Phase II Evaluation of Topotecan (NSC #609699) Administered Daily x 5 Every 3 Weeks vs Weekly Topotecan in the Treatment of Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving
topotecan in different dosing schedules may kill more tumor cells.
PURPOSE: This phase II trial is studying how well topotecan works in treating patients with
recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.
Detailed Description
OBJECTIVES:
Primary
- Determine the antitumor activity of topotecan, in terms of frequency and duration of
tumor response, in patients with recurrent platinum-sensitive ovarian epithelial,
fallopian tube, or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this regimen in these patients.
Secondary
- Determine the duration of progression-free survival and overall survival in patients
treated with these regimens.
- Determine the effects of prognostic variables (i.e., initial performance status, age,
and mucinous or clear cell histology) in patients treated with these regimens.
OUTLINE: This is a multicenter study.
Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 38-110 patients (19-55 per treatment arm) will be accrued
for this study within 15-30 months.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective Tumor Response
Secondary Outcome
Reason Off Study Therapy
Condition
Fallopian Tube Cancer
Intervention
topotecan hydrochloride
Study Arms / Comparison Groups
Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle
Description: Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle until disease progression or adverse effects prohibit further therapy
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
Estimated Enrollment
81
Start Date
January 2005
Primary Completion Date
January 2011
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal
cancer
- Recurrent disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan
- At least 1 target lesion not in a previously irradiated field
- Received 1, and only 1, prior platinum-based chemotherapy regimen for primary disease
containing carboplatin, cisplatin, or other organoplatinum compound
- Initial treatment may have included high-dose, consolidation, or extended therapy
administered after surgical or non-surgical assessment
- Patients who have not received prior paclitaxel may receive a second regimen that
includes paclitaxel
- Platinum-sensitive disease
- Treatment-free interval* without clinical evidence of progressive disease for > 6
months after prior response to a platinum-based regimen NOTE: *Non-platinum
maintenance or consolidation therapy is not included in calculation of the
treatment-free interval
- Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG
protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- GOG 0-2
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 > 40 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No sensory or motor neuropathy > grade 1
- No active infection requiring antibiotics
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 3 weeks since prior biologic or immunologic agents for the malignancy
- No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal
antibodies, cytokines, or small molecule inhibitors of signal transduction) for
recurrent disease
- No concurrent cytokines during the first course of study treatment
- No concurrent pegfilgrastim
Chemotherapy
- See Disease Characteristics
- See Biologic therapy
- Recovered from prior chemotherapy
- No other prior cytotoxic chemotherapy for recurrent disease, including retreatment
with initial chemotherapy regimen
- No prior topotecan
Endocrine therapy
- At least 1 week since prior hormonal therapy for the malignancy
- Concurrent hormone replacement therapy allowed
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
- No prior radiotherapy to > 25% of marrow-bearing areas
Surgery
- Recovered from prior surgery
Other
- At least 3 weeks since other prior therapy for the malignancy
- No prior anticancer therapy that would preclude study treatment
Gender
Female
Ages
18 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Thomas J. Herzog, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00114166
Organization ID
GOG-0146Q
Secondary IDs
GOG-0146Q
Responsible Party
Sponsor
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Thomas J. Herzog, MD, Study Chair, Herbert Irving Comprehensive Cancer Center
Verification Date
May 2014