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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114166
• Other study ID #: GOG-0146Q
• Secondary ID: GOG-0146QCDR0000
• Status: Completed
• Phase: Phase 2
• Start date: January 2005

Study information

• Verified date: May 2014
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• topotecan hydrochloride

Locations

Country	Name	City	State
United States	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
United States	Harrington Cancer Center	Amarillo	Texas
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan
United States	MBCCOP - Medical College of Georgia Cancer Center	Augusta	Georgia
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	Woman's Hospital	Baton Rouge	Louisiana
United States	Tufts-NEMC Cancer Center	Boston	Massachusetts
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Illinois Cancer Center	Chicago	Illinois
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Cleveland Clinic Cancer Center at Fairview Hospital	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Mount Carmel Health - West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Union Hospital Cancer Program at Union Hospital	Elkton	Maryland
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Foote Memorial Hospital	Jackson	Michigan
United States	University of Mississippi Cancer Clinic	Jackson	Mississippi
United States	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware
United States	Cancer Resource Center - Lincoln	Lincoln	Nebraska
United States	St. Mary Mercy Hospital	Livonia	Michigan
United States	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin
United States	Hillcrest Cancer Center at Hillcrest Hospital	Mayfield Heights	Ohio
United States	Lake/University Ireland Cancer Center	Mentor	Ohio
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Jersey Shore Cancer Center at Jersey Shore University Medical Center	Neptune	New Jersey
United States	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus	New Britain	Connecticut
United States	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	New York	New York
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Methodist Estabrook Cancer Center	Omaha	Nebraska
United States	Cancer Center of Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Advocate Lutheran General Cancer Care Center	Park Ridge	Illinois
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	St. Joseph Mercy Oakland	Pontiac	Michigan
United States	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan
United States	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Marshfield Clinic - Indianhead Center	Rice Lake	Wisconsin
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan
United States	Saint Louis University Cancer Center	Saint Louis	Missouri
United States	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	South Dakota
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Stony Brook University Cancer Center	Stony Brook	New York
United States	Cancer Care Associates - Midtown Tulsa	Tulsa	Oklahoma
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	St. John Macomb Hospital	Warren	Michigan
United States	Washington Cancer Institute at Washington Hospital Center	Washington	District of Columbia
United States	Marshfield Clinic - Weston Center	Weston	Wisconsin
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina
United States	UMASS Memorial Cancer Center - University Campus	Worcester	Massachusetts
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Herzog TJ, Sill MW, Walker JL, O'Malley D, Shahin M, DeGeest K, Weiner SA, Mutch D, DeBernardo RL, Lentz SS. A phase II study of two topotecan regimens evaluated in recurrent platinum-sensitive ovarian, fallopian tube or primary peritoneal cancer: a Gynec — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Tumor Response	Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.; Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.; Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.; Stable Disease is any condition not meeting the above criteria.; Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.	Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal
Primary	Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0		Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Secondary	Reason Off Study Therapy		study entry through end of study treatment, up to 5 years