Topotecan in Treating Patients With Gynecologic Cancer That Cannot Be Removed by Surgery

NCT ID: NCT00842452

Last Updated: 2013-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2011-04-30

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.

PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in treating patients with gynecologic cancer that cannot be removed by surgery.

Detailed Description

OBJECTIVES:

Primary

• To establish the maximum tolerated dose (MTD) of oral topotecan hydrochloride in patients with unresectable gynecologic malignancies.
• To determine the safety and tolerability of this drug in these patients.
• To obtain pharmacokinetic data to assess plasma concentrations of this drug when administered at the MTD.

Secondary

• To explore the response in patients treated with this drug.

OUTLINE: Patients receive oral topotecan hydrochloride on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients treated at the maximum tolerated dose undergo blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies.

Conditions

Cervical Cancer; Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Sarcoma; Vaginal Cancer; Vulvar Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Topotecan

Group Type: EXPERIMENTAL

topotecan hydrochloride

Intervention Type: DRUG

Patients receive oral topotecan hydrochloride on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

pharmacological study

Intervention Type: OTHER

Patients treated at the maximum tolerated dose undergo blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies.

Interventions

topotecan hydrochloride

Patients receive oral topotecan hydrochloride on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Intervention Type: DRUG

pharmacological study

Patients treated at the maximum tolerated dose undergo blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically* or cytologically confirmed unresectable gynecologic malignancy for which standard curative or palliative care is not available

• All tumor types allowed NOTE: *Histologic confirmation of recurrence is not required
• Measurable or nonmeasurable disease

• If CT scan was used to evaluate measurable disease, lesions must be clearly defined and be ≥ 10 mm on spiral CT scan
• No "borderline tumors" or tumors with low malignant potential

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%
• Life expectancy ≥ 12 weeks
• ANC ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Hemoglobin ≥ 9 g/dL
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Creatinine clearance ≥ 60 mL/min
• AST/ALT ≤ 2.5 times ULN (< 5 times ULN if liver metastases are present)
• Alkaline phosphatase ≤ 2.5 times ULN (< 5 times ULN if liver metastases are present)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Adequate intestinal function (i.e., no gastrostomy tube or requirement for IV hydration or nutritional support)
• No severe gastrointestinal bleeding or intestinal obstruction
• No other condition that would affect gastrointestinal absorption and motility
• No septicemia, severe infection, or acute hepatitis
• No other malignancies requiring chemotherapy or radiotherapy within the past 5 years, except skin cancer
• No concurrent severe medical problem unrelated to the malignancy that would significantly limit full compliance with the study, expose the patient to extreme risk, or decrease life expectancy

PRIOR CONCURRENT THERAPY:

• At least 28 days since prior investigational drugs (including cytotoxic drugs)
• At least 4 weeks since prior chemotherapy, radiotherapy, biologic therapy, or surgery and recovered
• No more than 3 prior chemotherapy regimens
• No prior topotecan hydrochloride or other camptothecin analogs
• No prior radiotherapy to > 25% of the bone marrow
• No other concurrent chemotherapy, radiotherapy, biologic therapy, immunotherapy, or hormonal therapy for cancer
• No concurrent administration of any of the following:

• P-glycoprotein (ABCB1, Pgp, MDR1) inhibitors or inducers
• Breast cancer-resistant protein (ABCG2, BCRP, MXR) inhibitors or inducers
• No concurrent chronic H2 antagonists, proton pump inhibitors, or antacids for gastritis, gastroesophageal reflux disease, or gastric or duodenal ulcers

• Intermittent antacid therapy is allowed provided it is given ≥ 6 hours prior to and ≥ 90 minutes after study drug administration

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Steven Waggoner, MD

OTHER

Sponsor Role: lead

Responsible Party

Steven Waggoner, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stephen Waggoner, MD

Role: PRINCIPAL_INVESTIGATOR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Locations

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE2Y08

Identifier Type: OTHER

Identifier Source: secondary_id

CASE 2Y08-CC630

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2009-01290

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE2Y08

Identifier Type: -

Identifier Source: org_study_id