Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI MDA-DM-93083 NCI-T93-0132D, T93-0132

Objectives

I.  Compare reduction of chemotherapy-induced myelosuppression with PIXY321 
administered by two different schedules.

II.  Evaluate the tolerance to and clinical safety of PIXY321 given in 
combination with paclitaxel (TAX) and carboplatin (CBDCA).

III.  Document the progression-free and overall survival and antitumor effects 
of TAX/CBDCA combined with PIXY321 in patients with gynecologic malignancies.

Entry Criteria

Disease Characteristics:

Histologically proven gynecologic malignancy suitable for chemotherapy with
carboplatin and taxol, i.e.:
  Cervical cancer
  Endometrial carcinoma
  Fallopian tube cancer
  Ovarian cancer
  Primary peritoneal adenocarcinoma
  Uterine sarcoma
  Vaginal cancer
  Vulvar cancer

Measurable or evaluable disease required

No rapidly progressive disease

No ascites or hepatic metastasis

No CNS disease

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  Prior chemotherapy eligible only with approval of Principal Investigator

Endocrine therapy:
  Not specified

Radiotherapy:
  More than 4 weeks since radiotherapy
  Prior pelvic irradiation eligible only with approval of Principal
     Investigator

Surgery:
  More than 2 weeks since any surgery

Patient Characteristics:

Age:
  18 and over

Performance status:
  Karnofsky 60-100%

Life expectancy:
  At least 12 weeks

Hematopoietic:
  AGC greater than 1,500
  Platelets greater than 100,000

Hepatic:
  Bilirubin no greater than 1.5 mg/dl

Renal:
  Creatinine no greater than 1.5 mg/dl

Cardiovascular:
  No NYHA class III/IV status
  Cardiology consult required for arrhythmia or a requirement for cardiac
     medications (e.g., digitalis, beta blockers, calcium channel blockers)

Other:
  No serious intercurrent illness
  No active infection
  No pregnant or nursing women
  Adequate contraception required of fertile women

Expected Enrollment

Up to 12 patients will be treated on Part I; 40 patients will be treated on 
the randomized portion of the study.  Accrual is expected to require 12-18 
months.

Outline

Once the optimal priming schedule is established in Part I, patients are 
randomized to Arms A and B in Part II.

Part I.

Biological Response Modifier Therapy followed by 2-Drug Combination 
Chemotherapy.  Granulocyte-Macrophage Colony-Stimulating Factor/Interleukin-3 
Fusion Protein, PIXY321, NSC-645014; followed by Carboplatin, CBDCA, 
NSC-241240; Paclitaxel, Taxol, TAX, NSC-125973.

Part II.

Arm A:  Biological Response Modifier Therapy followed by 2-Drug Combination 
Chemotherapy followed by Biological Response Modifier Therapy.  PIXY321; 
followed by CBDCA; TAX; followed by PIXY321.

Arm B:  2-Drug Combination Chemotherapy followed by Biological Response 
Modifier Therapy.  CBDCA; TAX; followed by PIXY321.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Saroj G. Vadhan-Raj, MD, Protocol chair		Ph: 713-792-7966; 800-392-1611