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A Phase I Study of Weekly Oral Topotecan in Gynecologic Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Female
Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma, Vaginal Cancer, Vulvar Cancer

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Trial Information

A Phase I Study of Weekly Oral Topotecan in Gynecologic Malignancies


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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD)

Outcome Time Frame:

Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.

Safety Issue:

Yes

Principal Investigator

Stephen Waggoner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Food and Drug Administration

Study ID:

CASE2Y08

NCT ID:

NCT00842452

Start Date:

February 2009

Completion Date:

April 2011

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Sarcoma
  • Vaginal Cancer
  • Vulvar Cancer
  • recurrent ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian germ cell tumor
  • stage III ovarian germ cell tumor
  • stage IV ovarian germ cell tumor
  • recurrent endometrial carcinoma
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • recurrent uterine sarcoma
  • stage III uterine sarcoma
  • stage IV uterine sarcoma
  • recurrent vaginal cancer
  • stage III vaginal cancer
  • stage IVA vaginal cancer
  • stage IVB vaginal cancer
  • recurrent vulvar cancer
  • stage III vulvar cancer
  • stage IV vulvar cancer
  • recurrent cervical cancer
  • stage III cervical cancer
  • stage IVA cervical cancer
  • stage IVB cervical cancer
  • fallopian tube cancer
  • ovarian sarcoma
  • ovarian stromal cancer
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms
  • Fallopian Tube Neoplasms
  • Adenoma
  • Sarcoma

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065