Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	GOG-0146Q NCT00114166

Objectives

Primary

1. 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.
2. Determine the nature and degree of toxicity of this regimen in these patients.

Secondary

1. Determine the duration of progression-free survival and overall survival in patients treated with these regimens.
2. Determine the effects of prognostic variables (i.e., initial performance status, age, and mucinous or clear cell histology) in patients treated with these regimens.

Entry 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)

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

Patient Characteristics:

Age

• 18 and over

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

Approximately 38-110 patients (19-55 per treatment arm) will be accrued for this study within 15-30 months.

Outcomes

Frequency and duration of objective response
Frequency and severity of observed adverse effects

Duration of progression-free survival
Duration of overall survival
Prognostic variables including initial performance status, age, mucinous (or clear cell) histology, and platinum-free interval

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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Thomas Herzog, MD, Protocol chair		Ph: 212-305-3410
David Cohn, MD, Protocol co-chair		Ph: 614-293-7460

Registry Information
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
Trial Start Date		2005-01-03
Trial Completion Date		2007-04-08 (estimated)
Registered in ClinicalTrials.gov		NCT00114166
Date Submitted to PDQ		2005-05-23
Information Last Verified		2009-02-24
NCI Grant/Contract Number		CA27469

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