AzTrials
AzTrials

Ovarian CancerPhase 1NCT00652691

Topotecan, High-Dose Cyclophosphamide, Carboplatin, and an Autologous Peripheral Blood Cell Transplant in Treating Patients With Recurrent Ovarian Cancer or Primary Peritoneal Cancer

A Phase 1 study testing filgrastim, carboplatin and cyclophosphamide in people with Ovarian Cancer and Peritoneal Cavity Cancer, run by Mayo Clinic.

Completed

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

Official record
Search all trials

Trial summary

RATIONALE: Giving colony-stimulating factors, such as G-CSF help stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Combination chemotherapy is then given to prepare the bone marrow for the stem cell transplant. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Ovarian Cancer, Peritoneal Cavity Cancer
What is being tested?
filgrastim, carboplatin and cyclophosphamide
Type of treatment
Surgery or procedure
How many people
48 participants
Where
No sites listed yet
Study dates
Aug 1998to 4 May 2016
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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer
  • Recurrent, relapsed, or persistent disease meeting 1 or more of the following criteria:
  • Patients with a positive second-look laparotomy who are not candidates for higher priority GOG protocols
  • Largest mass of recurrent disease ≤ 0.2 cm achieved by surgery or chemotherapy
  • Achievement of complete response to 1 prior regimen of platinum-based chemotherapy with relapse > 6 months from last chemotherapy
  • Achievement of partial response to 1 platinum-based chemotherapy regimen prior to study
  • Histological proof of disease recurrence with or without a rising serum CA-125 level (relapsed or recurrent disease)
  • The following histological cell types are allowed:
  • Clear-cell adenocarcinoma
  • Endometrioid adenocarcinoma
  • Mixed epithelial carcinoma
  • Mucinous adenocarcinoma
  • Serous adenocarcinoma
  • Undifferentiated carcinoma
  • Must have unilateral bone marrow aspirate and biopsy with cytogenetics without evidence of metastatic ovarian carcinoma by conventional morphology within 1 month of registration
  • Not eligible for GOG-164

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Creatinine ≤ 1.5 mg/dL
  • Total bilirubin ≤ 2.0 mg/dL (≤ 5.0 mg/dL with metastatic disease)
  • AST ≤ 2 times upper limit of normal (ULN) (≤ 600 units/mL with metastatic disease)
  • Alkaline phosphatase ≤ 2 times ULN (unless related to metastatic disease)
  • ANC ≥ 1,000/mm^3
  • Platelets ≥ 100,000/mm^3
  • Cardiac ejection fraction ≥ 45% by rest ECHO or MUGA
  • FEV_1 ≥ 50% of predicted
  • HIV negative
  • No uncontrolled infection
  • No severe medical or psychiatric illness, including any of the following:
  • Renal failure
  • Brittle insulin dependent diabetes mellitus
  • Congestive heart failure
  • History of myocardial infarction within the past 3 months
  • Significant arrhythmia requiring medication
  • Poorly controlled hypertension (diastolic blood pressure >100 mm Hg)
  • History of hospitalization for severe depression or psychosis
  • Significant non-neoplastic pulmonary disease
  • Current alcohol or drug abuse.
  • Active infection
  • Active peptic ulcer disease
  • No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No more than 1 prior treatment regimen for this cancer
  • More than 3 weeks since surgery
  • No prior topotecan hydrochloride

About this study

Official title: A Dose Seeking Trial of Topotecan Combined With High-Dose Cyclophosphamide and Carboplatin With Peripheral Blood Stem Cell Transplant for the Treatment of Relapsed Ovarian Cancer and Primary Peritoneal Cancer

RATIONALE: Giving colony-stimulating factors, such as G-CSF help stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Combination chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

PURPOSE: This randomized trial is studying the side effects and best dose of topotecan when given together with high-dose cyclophosphamide, and carboplatin followed by an autologous peripheral blood stem cell transplant in treating patients with recurrent ovarian cancer or primary peritoneal cancer.

Read the detailed description

OBJECTIVES:

  • To determine the maximum tolerated dose of topotecan hydrochloride combined with high-dose cyclophosphamide and carboplatin in the setting of autologous peripheral blood stem cell transplantation for relapsed, recurrent, or persistent ovarian epithelial or primary peritoneal cavity cancer.
  • To assess the toxicity of this regimen.

OUTLINE: This is a dose escalation study of topotecan.

  • Autologous hematopoietic stem cell collection: Patients receive filgrastim subcutaneously (SC) daily for 5 days. Patients undergo leukapheresis per standard practice until a minimum of 2 x10^6 CD34+ cells/kg are collected and cryopreserved.
  • High-dose chemotherapy: Patients receive topotecan hydrochloride IV, cyclophosphamide IV, and carboplatin IV over 8 hours on days -6 to -3.
  • Autologous peripheral stem cell reinfusion: Patients undergo autologous peripheral blood stem cell transplantation on day 0. Patients also receive sargramostim SC daily beginning on day 5 and continuing until blood counts recover.

After completion of study therapy, patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 5 years.

Being tested
filgrastim, carboplatin, cyclophosphamide, topotecan hydrochloride, autologous hematopoietic stem cell transplantation
Keywords
peritoneal cavity cancer, ovarian clear cell tumor with proliferating activity, ovarian endometrioid adenocarcinoma, ovarian mixed epithelial carcinoma, recurrent ovarian epithelial cancer, ovarian mucinous cystadenocarcinoma, ovarian serous cystadenocarcinoma, ovarian undifferentiated adenocarcinoma
Medical subject headings
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. Maximum tolerated dose of topotecan hydrochloride

  2. Toxicity according to NCI criteria

Timeline

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

  1. First posted4 Apr 2008 (estimated)
  2. Study startAug 1998
  3. Primary completion5 Jun 2002
  4. Study completion4 May 2016

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
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00652691
Sponsor's protocol ID
976101
Other IDs
P30CA015083, 976101, 1056-98
Status last verified
Mar 2018
First submitted
3 Apr 2008
Last updated
8 Apr 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Litzow MR, Peethambaram PP, Safgren SL, Keeney GL, Ansell SM, Dispenzieri A, Elliott MA, Gastineau DA, Gertz MA, Inwards DJ, Lacy MQ, Micallef IN, Porrata LF, Lingle WL, Hartmann LC, Frost MH, Barrette BA, Long HJ, Suman VJ, Reid JM, Ames MM, Kaufmann SH. Phase I trial of autologous hematopoietic SCT with escalating doses of topotecan combined with CY and carboplatin in patients with relapsed or persistent ovarian or primary peritoneal carcinoma. Bone Marrow Transplant. 2010 Mar;45(3):490-7. doi: 10.1038/bmt.2009.181. Epub 2009 Aug 3.

    PubMed 19648970

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing filgrastim, carboplatin and cyclophosphamide in people with Ovarian Cancer and Peritoneal Cavity Cancer, run by Mayo Clinic.

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 8 Apr 2019. 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?

Maximum tolerated dose of topotecan hydrochloride. The study lists 2 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 NCT00652691, which also lists 1 linked publication.

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 8 Apr 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in