Fallopian Tube CancerPhase 2NCT00003944
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 2 study testing filgrastim, carboplatin and cyclophosphamide in people with Fallopian Tube Cancer and Ovarian Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
- What is being tested?
- filgrastim, carboplatin and cyclophosphamide
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1998to Feb 2003
- Phase
- Phase 2
- 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
DISEASE CHARACTERISTICS: Histologically proven ovarian, fallopian tube, or primary peritoneal carcinoma Suboptimally debulked stage III (greater than 1.0 cm residual disease) Stage IV Histological subtypes allowed include: Serous adenocarcinoma Mucinous adenocarcinoma Clear cell carcinoma Transitional cell carcinoma Endometrioid adenocarcinoma Undifferentiated adenocarcinoma Mixed epithelial adenocarcinoma Adenocarcinoma not otherwise specified No borderline ovarian carcinoma of low malignant potential histology Stage III disease patients must have had appropriate surgery for ovarian, fallopian tube, and primary peritoneal carcinoma and retained suboptimally debulked disease (greater than 1.0 cm residual disease) No CNS involvement
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST and ALT no greater than 2 times upper limit of normal Hepatitis negative Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Ureteral obstruction must be successfully treated No renal failure Cardiovascular: No congestive heart failure No myocardial infarction within past 6 months No significant arrhythmias requiring medication No poorly controlled hypertension No poorly controlled systolic blood pressure No diastolic blood pressure consistently greater than 100 mmHg Pulmonary: No significant non-neoplastic pulmonary disease Other: No other severe medical disease HIV negative No prior malignancy within past 5 years except squamous or basal cell carcinoma of the skin, or carcinoma in situ of the cervix Second concurrent solid tumor malignancy allowed if not life threatening and if does not require chemotherapy or radiotherapy No acute infection No active peptic ulcer disease No uncontrolled diabetes mellitus No current psychiatric disease, alcohol abuse, or drug abuse No prior hospitalization for psychiatric disease including severe depression or psychosis Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No hypersensitivity to E. coli derived products
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to greater than 25% of bone marrow Surgery: See Disease Characteristics No greater than 8 weeks since debulking surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Phase II Trial Using Multiple Cycles of High Dose Sequential Carboplatin, Paclitaxel and Topotecan With Peripheral Blood Stem Cell (PBSC) Support as Initial Chemotherapy in Patients With Suboptimally Debulked Stage III or IV Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer.
Read the detailed description
OBJECTIVES: I. Determine pathological complete response rate in patients with suboptimally debulked stage III or stage IV ovarian, fallopian tube, or primary peritoneal carcinoma treated with sequential paclitaxel, carboplatin, and topotecan with peripheral blood stem cell rescue. II. Determine disease free and overall survival of these patients.
OUTLINE: Patients receive mobilization with cyclophosphamide IV over 1 hour, followed 4 hours later by paclitaxel IV over 24 hours. Filgrastim (G-CSF) is administered subcutaneously beginning 24 hours after completion of paclitaxel and continues through stem cell harvest. Peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells. High dose sequential chemotherapy begins 21 days after leukapheresis. Patients receive paclitaxel IV over 24 hours on day 1, carboplatin IV over 2 hours on day 2, and then topotecan IV over 24 hours. G-CSF is administered subcutaneously beginning on day 3 until blood counts recover. PBSC are reinfused on day 4. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with radiographic and biochemical complete response undergo second look surgery within 8 weeks of completing the last course of chemotherapy.
PROJECTED ACCRUAL: Approximately 28 patients will be accrued for this study.
- Being tested
- filgrastim, carboplatin, cyclophosphamide, paclitaxel, topotecan hydrochloride
- Keywords
- stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, ovarian undifferentiated adenocarcinoma, ovarian mixed epithelial carcinoma, ovarian serous cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian clear cell cystadenocarcinoma, fallopian tube cancer, peritoneal cavity cancer
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
carboplatinDrug
cyclophosphamideDrug
paclitaxelDrug
topotecan hydrochlorideDrug
peripheral blood stem cell transplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2004 (estimated)
- Study startAug 1998
- Primary completionDec 1999
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube CancerStudies 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 2
- Primary purpose
- Treatment
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Russell J. Schilder, MD, Study chair, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003944
- Sponsor's protocol ID
- CDR0000067137
- Other IDs
- FCCC-98030, NCI-G99-1536
- Status last verified
- Apr 2013
- First submitted
- 1 Nov 1999
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Using Multiple Cycles of High Dose Sequential Carboplatin, Paclitaxel and Topotecan With Peripheral Blood Stem Cell (PBSC) Support as Initial Chemotherapy in Patients With Suboptimally Debulked Stage III or IV Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
- ClinicalTrials.gov ID
- NCT00003944
- Acronym / sponsor ID
- CDR0000067137
- Keywords
- stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, ovarian undifferentiated adenocarcinoma, ovarian mixed epithelial carcinoma, ovarian serous cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian clear cell cystadenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 1998
- Primary completion
- Dec 1999 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 25 May 2004 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer.
Detailed description
OBJECTIVES: I. Determine pathological complete response rate in patients with suboptimally debulked stage III or stage IV ovarian, fallopian tube, or primary peritoneal carcinoma treated with sequential paclitaxel, carboplatin, and topotecan with peripheral blood stem cell rescue. II. Determine disease free and overall survival of these patients.
OUTLINE: Patients receive mobilization with cyclophosphamide IV over 1 hour, followed 4 hours later by paclitaxel IV over 24 hours. Filgrastim (G-CSF) is administered subcutaneously beginning 24 hours after completion of paclitaxel and continues through stem cell harvest. Peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells. High dose sequential chemotherapy begins 21 days after leukapheresis. Patients receive paclitaxel IV over 24 hours on day 1, carboplatin IV over 2 hours on day 2, and then topotecan IV over 24 hours. G-CSF is administered subcutaneously beginning on day 3 until blood counts recover. PBSC are reinfused on day 4. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with radiographic and biochemical complete response undergo second look surgery within 8 weeks of completing the last course of chemotherapy.
PROJECTED ACCRUAL: Approximately 28 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| filgrastim | Biological | – |
| carboplatin | Drug | – |
| cyclophosphamide | Drug | – |
| paclitaxel | Drug | – |
| topotecan hydrochloride | Drug | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 17 Apr 2013.
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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.
Russell J. Schilder, MD study chair
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim, carboplatin and cyclophosphamide in people with Fallopian Tube Cancer and Ovarian Cancer, run by Fox Chase Cancer Center at 1 site 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?
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 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 17 Apr 2013.