Fallopian Tube CarcinomaPhase 1NCT00352300
Carboplatin, Paclitaxel, and Pegfilgrastim in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, Primary Peritoneal, or Carcinosarcoma Cancer
A Phase 1 study testing Adjuvant Therapy, Carboplatin and Paclitaxel in people with Fallopian Tube Carcinoma and Infectious Disorder, run by Gynecologic Oncology Group at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Carcinoma, Infectious Disorder, Neutropenia
- What is being tested?
- Adjuvant Therapy, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 11 sitesUnited States
- Study dates
- Jun 2006to Jul 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of 1 of the following:
- Primary peritoneal carcinoma
- Fallopian tube carcinoma
- Ovarian epithelial carcinoma
- Carcinosarcoma
- Stage III or IV disease
Show all 24Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
Riverside Methodist Hospital
Columbus, Ohio, 43214
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Lake University Ireland Cancer Center
Mentor, Ohio, 44060
New York University Langone Medical Center
New York, New York, 10016
University of California Medical Center At Irvine-Orange Campus
Orange, California, 92868
Women and Infants Hospital
Providence, Rhode Island, 02905
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
University of Washington Medical Center
Seattle, Washington, 98195
Cancer Care Associates-Midtown
Tulsa, Oklahoma, 74104
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Fallopian Tube Carcinoma, Infectious Disorder, Neutropenia, Ovarian Carcinosarcoma, Primary Peritoneal Carcinoma, Stage III Ovarian Cancer
- Being tested
- Adjuvant Therapy, Carboplatin, Paclitaxel, Pegfilgrastim
- Medical subject headings
- Fallopian Tube Neoplasms, Communicable Diseases, Neutropenia, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant TherapyProcedure or surgery
CarboplatinDrug
Given IV
PaclitaxelDrug
Also called Anzatax, TAX
Given IV
PegfilgrastimBiological
Also called Filgrastim SD-01, GCSF-SD01, Neulasta
Given IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Adjuvant Therapy; Drug: Carboplatin; Drug: Paclitaxel; Biological: Pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (3)
Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale
Measured: Up to 1 year
Frequency and duration of objective response (complete and partial response) assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Measured: Up to 1 year
Grade of toxicity as assessed by CTCAE v3.0
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Amy Tiersten, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352300
- Sponsor's protocol ID
- GOG-9919
- Other IDs
- NCI-2009-00622, CDR0000486412, GOG-9919, GOG-9919, GOG-9919, U10CA027469
- Status last verified
- Dec 2014
- First submitted
- 13 Jul 2006
- Last updated
- 31 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00352300
- Acronym / sponsor ID
- GOG-9919
- Conditions
- Fallopian Tube Carcinoma, Infectious Disorder, Neutropenia, Ovarian Carcinosarcoma, Primary Peritoneal Carcinoma, Stage III Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2006
- Primary completion
- Jul 2010 (actual)
- First posted
- 14 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (carboplatin, paclitaxel, pegfilgrastim) | Experimental | Procedure: Adjuvant Therapy, Drug: Carboplatin, Drug: Paclitaxel, Biological: PegfilgrastimPatients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjuvant Therapy | Procedure or surgery | Treatment (carboplatin, paclitaxel, pegfilgrastim) |
| CarboplatinGiven IV | Drug | Treatment (carboplatin, paclitaxel, pegfilgrastim) |
| PaclitaxelAlso: Anzatax, TAXGiven IV | Drug | Treatment (carboplatin, paclitaxel, pegfilgrastim) |
| PegfilgrastimAlso: Filgrastim SD-01, GCSF-SD01, NeulastaGiven IV | Biological | Treatment (carboplatin, paclitaxel, pegfilgrastim) |
Primary outcome
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)
Time frame: 12 weeks
3 secondary outcomes
Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale
Time frame: Up to 1 year
Frequency and duration of objective response (complete and partial response) assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Time frame: Up to 1 year
Grade of toxicity as assessed by CTCAE v3.0
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Tiersten principal investigator
Gynecologic Oncology Group
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adjuvant Therapy, Carboplatin and Paclitaxel in people with Fallopian Tube Carcinoma and Infectious Disorder, run by Gynecologic Oncology Group at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.