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AzTrials

Fallopian Tube CancerPhase 1NCT00550784

Combination Chemotherapy and Autologous Peripheral Stem Cell Transplant in Treating Patients With Stage III, Stage IV, or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

A Phase 1 study testing filgrastim, cisplatin and cyclophosphamide in people with Fallopian Tube Cancer and Ovarian Cancer, run by City of Hope Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Giving chemotherapy before a peripheral stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and… Read more about this study

Who is it for?
Ages Up to 60 years, women only
What is being tested?
filgrastim, cisplatin and cyclophosphamide
Type of treatment
Surgery or procedure
How many people
8 participants
Where
No sites listed yet
Study dates
Jan 2001to Oct 2014
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 Up to 60 years
  • Women only
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial carcinoma, primary peritoneal cavity carcinoma, or epithelial carcinoma of the fallopian tubes, meeting 1 of the following criteria:
  • Stage III or IV disease that was treated with initial therapy comprising a standard platinum-containing regimen
  • Must have < 2 cm of residual disease with no evidence of disease progression after initial chemotherapy AND have no disease progression immediately prior to stem cell collection
  • Patients initially presenting with stage IV disease who have achieved a clinical response (complete response [CR] or partial response [PR]) after initial therapy are eligible
  • Responding recurrent disease
  • Patients who have had recurrence with elevated CA 125 levels (> 100 U/mL) and who have achieved a reduction of CA 125 level by 50% for 4 weeks following the most recent course of reinduction chemotherapy are eligible
  • Patients who have achieved a CR or PR after salvage chemotherapy for relapsed disease are eligible
  • Patients with measurable or evaluable disease must have achieved a PR after prior therapy
  • No clinically significant pleural effusions

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • ANC > 1,000/μL
  • Platelet count > 100,000/μL
  • Serum bilirubin < 1.5 mg/dL
  • SGOT and SGPT ≤ 2.5 times normal
  • Creatinine clearance ≥ 60 mL/min
  • No active cardiac disease that, in the opinion of the investigator, would preclude safe administration of chemotherapy
  • Cardiac ejection fraction normal at rest by MUGA
  • No history of potentially disabling psychiatric disorders
  • Hepatitis B antigen, hepatitis C antibody, and HIV antibody negative
  • No clinically significant peripheral neuropathy
  • FEV_1 ≥ 2.0 L or ≥ 75% of the lower limit of normal

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy or radiotherapy
  • No prior radiotherapy to the whole abdomen

About this study

Official title: Phase I Trial of Tandem Chemotherapy Cycles as Consolidation Therapy for High-Risk Epithelial Ovarian and Primary Peritoneal Cancer Utilizing Intraperitoneal Paclitaxel/IV Cyclophosphamide Followed by IV Topotecan/Intraperitoneal Cisplatin/IV Melphalan Using Hematopoietic Stem Cell Support

RATIONALE: Giving chemotherapy before a peripheral stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with cyclophosphamide, paclitaxel, melphalan, and cisplatin, followed by an autologous peripheral stem cell transplant in treating patients with stage III, stage IV, or recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.

Read the detailed description

OBJECTIVES:

  • To establish the maximum tolerated dose (MTD) of continuous infusion intravenous topotecan hydrochloride when administered with intraperitoneal (IP) cisplatin and intravenous melphalan in patients with stage III, stage IV, or recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.
  • To describe the toxicities of each dose studied.
  • To evaluate the pharmacokinetics of topotecan hydrochloride when administered at the maximum tolerated dose and cisplatin.
  • To confirm the pharmacokinetic advantage of high-dose IP cisplatin and IP paclitaxel.
  • To obtain tissue at the time of peritoneal catheter placement in order to evaluate the molecular determinants of apoptosis (including p53 status, p21 gene expression, bcl-2 gene expression, and bcl-2/bax ratio) and the extent of apoptosis by the TdT assay.
  • To evaluate the molecular determinants of DNA damage and repair, including expression levels of ERCC1 and MDR1, and HER2/neu expression by immunohistochemistry.

OUTLINE: This is a dose-escalation study of topotecan hydrochloride.

Patients undergo surgical placement of an intraperitoneal (IP) catheter. Tumor biopsies are obtained during surgery for laboratory analysis of molecular determinants of apoptosis (including p53 status, p21 gene expression, bcl-2 gene expression, bcl-2/bax ratio) and molecular determinants of DNA damage and repair (including expression levels of ERCC1 and MDR1, and HER2/neu expression by immunohistochemistry). The extent of apoptosis is also assessed using the TdT assay.

  • Course 1: Patients receive paclitaxel IP on day 1, cyclophosphamide IV on day 2, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 3 and continuing until apheresis is completed. Patients undergo apheresis until ≥ 2.5 X 10^6 CD34-positive cells/kg are collected. Two weeks later, patients proceed to course 2.
  • Course 2: Patients receive cisplatin IP and melphalan IV on days -11 and -4 and topotecan hydrochloride by continuous infusion over 120 hours on days -10 to -6. Patients receive 25% of their peripheral blood stem cells (PBSCs) on day -3 and G-CSF IV beginning on day -3 and continuing until blood counts recover. Patients receive their remaining PBSCs on day 0.

Patients undergo daily blood sample collection during topotecan hydrochloride administration for pharmacokinetic studies. Patients treated at the maximum tolerated dose of topotecan hydrochloride undergo additional blood sample collections for pharmacokinetic studies.

After completion of study therapy, patients are followed every 3 months.

Keywords
recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicity

  2. Tumor response

  3. Reason patient is removed from study

  4. Disease progression

  5. Overall survival

  6. Progression-free survival

  7. Time to progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2007 (estimated)
  2. Study startJan 2001
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

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
Non-randomised
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00550784
Sponsor's protocol ID
00067
Other IDs
P30CA033572, CHNMC-00067, CCC-PHI-31, CDR0000567474
Status last verified
Oct 2014
First submitted
22 Oct 2007
Last updated
7 Oct 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing filgrastim, cisplatin and cyclophosphamide in people with Fallopian Tube Cancer and Ovarian Cancer, run by City of Hope Medical Center.

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 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

Toxicity. The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00550784.

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 7 Oct 2014.

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