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A Phase I Trial of Dose Dense (Biweekly) Carboplatin Combined With Paclitaxel and Pegfilgrastim (Neulasta): A Feasibility Study in Patients With Untreated Stage III and IV Ovarian, Tubal or Primary Peritoneal Cancer


Phase 1
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Infection, Neutropenia, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

A Phase I Trial of Dose Dense (Biweekly) Carboplatin Combined With Paclitaxel and Pegfilgrastim (Neulasta): A Feasibility Study in Patients With Untreated Stage III and IV Ovarian, Tubal or Primary Peritoneal Cancer


OBJECTIVES:

Primary

- Establish the feasibility of adjuvant dose-dense carboplatin and paclitaxel followed by
pegfilgrastim, in terms of absence of grade 3 or 4 nonhematologic toxicities without
major dose delays or additional hematological support (e.g., red blood cell or platelet
transfusions or admission for febrile neutropenia), in patients with stage III-IV
ovarian epithelial, fallopian tube, primary peritoneal cancer, or carcinosarcoma
cancer.

Secondary

- Estimate the percentage of patients who develop ≥ grade 2 peripheral neurotoxicity from
this regimen.

- Estimate the clinical response rate in patients with measurable disease treated with
this regimen.

- Assess the toxicity of this regimen.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also
receive pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for up to 8
courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of 1 of the following:

- Primary peritoneal carcinoma

- Fallopian tube carcinoma

- Ovarian epithelial carcinoma

- Carcinosarcoma

- Stage III or IV disease

- Previously untreated disease, except for mandatory prior surgery

- No ovarian epithelial carcinoma of low malignant potential (i.e., borderline
carcinomas)

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9.0 g/dL

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- No peripheral neuropathy (sensory or motor) ≥ grade 2

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other invasive malignancies within the past 5 years except nonmelanoma skin cancer

- No septicemia, severe infection, or acute hepatitis

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior radiotherapy or chemotherapy

- No prior cancer treatment that would contraindicate study treatment

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients who have ≥ 1 dose-limiting toxicity during 6 courses of treatment

Safety Issue:

Yes

Principal Investigator

Amy D. Tiersten, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000486412

NCT ID:

NCT00352300

Start Date:

June 2006

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Infection
  • Neutropenia
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • infection
  • neutropenia
  • primary peritoneal cavity cancer
  • fallopian tube cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • ovarian carcinosarcoma
  • Carcinosarcoma
  • Mixed Tumor, Mullerian
  • Neutropenia
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Women and Infants Hospital of Rhode Island Providence, Rhode Island  02905
NYU Cancer Institute at New York University Medical Center New York, New York  10016
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange, California  92868
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
Cancer Care Associates - Saint Francis Campus Tulsa, Oklahoma  74136-1929