Clinical trial NCT00352300: Carboplatin, Paclitaxel, and Pegfilgrastim in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, Primary Peritoneal, or Carcinosarcoma Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fallopian Tube Carcinoma
Infectious Disorder
Neutropenia
Ovarian Carcinosarcoma
Primary Peritoneal Carcinoma
Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-07-14
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase I trial is studying the side effects of giving carboplatin and paclitaxel together with pegfilgrastim in treating patients with stage III or stage IV ovarian epithelial, fallopian tube, primary peritoneal, or carcinosarcoma cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving carboplatin and paclitaxel together with pegfilgrastim after surgery may kill any tumor cells that remain after surgery.

Detailed description: PRIMARY OBJECTIVES:

I. 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 OBJECTIVES:

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

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

III. 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.

Eligibility criteria: Inclusion Criteria:

* 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)
* 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
* No prior radiotherapy or chemotherapy
* No prior cancer treatment that would contraindicate study treatment

Primary outcomes:
measure: Number of patients who have greater than or equal to 1 dose-limiting toxicity, assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale
timeFrame: Up to 1 year
measure: Frequency and duration of objective response (complete and partial response) assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
timeFrame: Up to 1 year
measure: Grade of toxicity as assessed by CTCAE v3.0
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Medical Center At Irvine-Orange Campus
state: California
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Camden
country: United States
facility: Cooper Hospital University Medical Center
state: New Jersey
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Mentor
country: United States
facility: Lake University Ireland Cancer Center
state: Ohio
city: Tulsa
country: United States
facility: Cancer Care Associates-Midtown
state: Oklahoma
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Gynecologic Oncology Group
name: Amy Tiersten
role: PRINCIPAL_INVESTIGATOR
References: