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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00622 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000486412 | |||
| GOG-9919 | |||
| GOG-9919 | Other Identifier | Gynecologic Oncology Group | |
| GOG-9919 | Other Identifier | CTEP | |
| U10CA027469 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (carboplatin, paclitaxel, pegfilgrastim) | Experimental | Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant Therapy | Procedure |
| ||
| Carboplatin |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale | Up to 1 year | |
| Frequency and duration of objective response (complete and partial response) assessed by Response Evaluation Criteria for Solid Tumors (RECIST) |
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Inclusion Criteria:
Diagnosis of 1 of the following:
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
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| Name | Affiliation | Role |
|---|---|---|
| Amy Tiersten | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Medical Center At Irvine-Orange Campus | Orange | California | 92868 | United States | ||
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| Drug |
Given IV |
|
| Paclitaxel | Drug | Given IV |
|
|
| Pegfilgrastim | Biological | Given IV |
|
|
| Up to 1 year |
| Grade of toxicity as assessed by CTCAE v3.0 | Up to 1 year |
| University of Iowa Hospitals and Clinics |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| Cooper Hospital University Medical Center | Camden | New Jersey | 08103 | United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Lake University Ireland Cancer Center | Mentor | Ohio | 44060 | United States |
| Cancer Care Associates-Midtown | Tulsa | Oklahoma | 74104 | United States |
| Women and Infants Hospital | Providence | Rhode Island | 02905 | United States |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D003141 | Communicable Diseases |
| D009503 | Neutropenia |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D013660 | Taxes |
| C455861 | pegfilgrastim |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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