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A Phase II, Open, Randomized Multicenter Trial to Assess the Efficacy and Tolerability of Intravenous ZD9331 Given as Monotherapy (at Two Doses) or in Combination With Topotecan, in Patients With Ovarian Cancer Refractory or Recurrent After Failing Platinum and Paclitaxel in Combination


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

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Trial Information

A Phase II, Open, Randomized Multicenter Trial to Assess the Efficacy and Tolerability of Intravenous ZD9331 Given as Monotherapy (at Two Doses) or in Combination With Topotecan, in Patients With Ovarian Cancer Refractory or Recurrent After Failing Platinum and Paclitaxel in Combination


OBJECTIVES: I. Compare the efficacy of ZD9331 with or without topotecan in patients with
refractory or recurrent ovarian epithelial, primary peritoneal, or fallopian tube cancer.
II. Compare the tolerability of these regimens in these patients. III. Compare the objective
tumor response rate, progression-free survival, and disease control in patients treated with
these regimens. IV. Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1
of 3 treatment arms. Arm I: Patients receive ZD9331 IV over 30 minutes on days 1 and 8. Arm
II: Patients receive a higher dose of ZD9331 IV over 30 minutes on days 1 and 8. Arm III:
Patients receive ZD9331 as in arm I and topotecan IV over 30 minutes on days 1-5. All arms:
Treatment repeats every 21 days in the absence of disease progression or unacceptable
toxicity. Quality of life is assessed at baseline, on the first day of each course, and then
at study withdrawal. Patients are followed at day 30, every 9 weeks until disease
progression, and then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 130 patients will be accrued for this study within 5
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed ovarian epithelial
cancer, primary peritoneal cancer, or fallopian tube cancer Refractory or recurrent
disease after combination platinum and paclitaxel as only prior chemotherapy regimen
Platinum resistant (i.e., refractory or relapsed within 6 months after completion of last
therapy regimen) No more than 2 prior platinum and paclitaxel combination regimens
Measurable disease No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy:
More than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at
least 100,000/mm3 Hepatic: No unstable or uncompensated hepatic disease Bilirubin less
than 1.25 times upper limit of normal (ULN) Albumin at least lower limit of normal ALT or
AST no greater than 2.5 times ULN (5 times ULN if liver metastases present) Renal: No
unstable or uncompensated renal disease Creatinine clearance at least 60 mL/min
Cardiovascular: No unstable or uncompensated cardiac disease Pulmonary: No unstable or
uncompensated respiratory disease Other: No concurrent intestinal obstruction No evidence
of severe or uncontrolled systemic disease No other active malignancy within the past 5
years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix No
severe concurrent condition that would preclude study compliance No risk of transmitting
HIV or hepatitis B or C Not pregnant or nursing Negative pregnancy test Fertile patients
must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: No prior extensive
radiotherapy to more than 30% of bone marrow (e.g., whole pelvis or half of spine) No
concurrent radiotherapy for ovarian cancer Surgery: At least 2 weeks since prior
surgery,except for insertion of central venous access device, and recovered Other: At
least 4 weeks since other anticancer therapy and recovered Concurrent folic acid in a
nutritional supplement allowed except within the 24 hours before and after ZD9331 dosing
No other concurrent study drugs No other concurrent systemic therapy for ovarian cancer

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Bernadette Matthews, RN, MSN, CCRA

Investigator Role:

Study Chair

Investigator Affiliation:

AstraZeneca

Authority:

United States: Federal Government

Study ID:

CDR0000068604

NCT ID:

NCT00014690

Start Date:

March 2001

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
AstraZeneca Pharmaceuticals LP Wilmington, Delaware  19850-5437