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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and duration of objective response

Safety Issue:

No

Principal Investigator

Thomas J. Herzog, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000434848

NCT ID:

NCT00114166

Start Date:

January 2005

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Hurley Medical Center Flint, Michigan  48503
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Carle Cancer Center Urbana, Illinois  61801
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain, Connecticut  06050
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Hinsdale Hematology Oncology Associates Hinsdale, Illinois  60521
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Tufts-NEMC Cancer Center Boston, Massachusetts  02111
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Avera Cancer Institute Sioux Falls, South Dakota  57105
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Marshfield Clinic - Indianhead Center Rice Lake, Wisconsin  54868
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
Harrington Cancer Center Amarillo, Texas  79106
Rush University Medical Center Chicago, Illinois  60612-3824
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Washington Cancer Institute at Washington Hospital Center Washington, District of Columbia  20010
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
SUNY Downstate Medical Center Brooklyn, New York  11203
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
Lake/University Ireland Cancer Center Mentor, Ohio  44060
Cancer Care Associates - Midtown Tulsa Tulsa, Oklahoma  74104
Stony Brook University Cancer Center Stony Brook, New York  11794-8174
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
William Beaumont Hospital - Royal Oak Campus Royal Oak, Michigan  48073
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
MBCCOP - Medical College of Georgia Cancer Center Augusta, Georgia  30912-3730
University of Illinois Cancer Center Chicago, Illinois  60612-7243
Advocate Lutheran General Cancer Care Center Park Ridge, Illinois  60068-1174
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center New York, New York  10032
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Cleveland Clinic Cancer Center at Fairview Hospital Cleveland, Ohio  44111
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Hillcrest Cancer Center at Hillcrest Hospital Mayfield Heights, Ohio  44124
Rosenfeld Cancer Center at Abington Memorial Hospital Abington, Pennsylvania  19001
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
Cancer Resource Center - Lincoln Lincoln, Nebraska  68510
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Union Hospital Cancer Program at Union Hospital Elkton MD, Maryland  21921
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Marshfield Clinic - Weston Center Weston, Wisconsin  54476
Woman's Hospital Baton Rouge, Louisiana  70815
Saint Louis University Cancer Center Saint Louis, Missouri  63110
Cancer Center of Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
Jersey Shore Cancer Center at Jersey Shore University Medical Center Neptune, New Jersey  07754-0397