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Malignant Ovarian Mixed Epithelial TumorPhase 2NCT00004221

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer

A Phase 2 study testing Carboplatin, Cyclophosphamide and Filgrastim in people with Malignant Ovarian Mixed Epithelial Tumor and Ovarian Clear Cell Cystadenocarcinoma, run by Gynecologic Oncology Group at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have undergone surgery for stage III ovarian cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Carboplatin, Cyclophosphamide and Filgrastim
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Nov 1999to 6 Feb 2002
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

Who may be able to join

  • Histologically proven optimally debulked stage III ovarian or primary peritoneal carcinoma
  • Any of the following subtypes:
  • Serous adenocarcinoma
  • Mucinous adenocarcinoma
  • Clear cell carcinoma
  • Transitional cell carcinoma
Show all 42Show fewer
  • Endometrioid adenocarcinoma
  • Undifferentiated adenocarcinoma
  • Mixed epithelial adenocarcinoma
  • Adenocarcinoma, not otherwise specified
  • No ovarian carcinoma of low malignant potential (borderline)
  • Concurrent superficial endometrial or cervical carcinoma allowed if ovarian carcinoma more life threatening or limiting
  • Must have undergone appropriate primary surgical staging and debulking for ovarian carcinoma and have less than 1 cm of residual disease
  • No more than 8 weeks since prior surgical debulking
  • Must have Hickman catheter in place or be eligible for placement
  • No CNS involvement
  • Performance status - GOG 0 or 1
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 mg/dL
  • SGOT or SGPT no greater than 2 times upper limit of normal
  • No active hepatitis
  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min
  • No renal failure
  • Curatively treated ureteral obstruction allowed if above creatinine measurements met
  • No congestive heart failure
  • No myocardial infarction within the past 6 months
  • No significant arrhythmias requiring medication
  • No poorly controlled systolic or diastolic hypertension (diastolic blood pressure consistently greater than 100 mm Hg)
  • No significant nonneoplastic pulmonary disease
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • HIV negative
  • No other severe medical or psychiatric illness including, but not limited to the following:
  • Acute infection
  • Active peptic ulcer disease
  • Uncontrolled diabetes mellitus
  • Prior hospitalization for psychiatric illness, including severe depression or psychosis
  • Concurrent alcohol or drug abuse
  • No prior chemotherapy for this malignancy
  • No radiotherapy to greater than 25% of bone marrow
  • See Disease Characteristics

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Gynecologic Oncology Group

    Philadelphia, Pennsylvania, 19103

Other trials in United States

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 Optimally Debulked Stage III Ovarian and Primary Peritoneal Carcinoma

Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have undergone surgery for stage III ovarian cancer. 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 the detailed description

OBJECTIVES:

  1. Determine the safety and feasibility of multiple courses of high dose carboplatin, paclitaxel, and topotecan as initial chemotherapy combined with autologous peripheral blood stem cell transplantation in patients with optimally debulked stage III ovarian or primary peritoneal carcinoma.

II. Determine the pathological complete response rate, disease free survival, and overall survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Mobilization and harvest: Within 8 weeks of surgical debulking, patients receive cyclophosphamide IV over 1 hour, followed 4 hours later by paclitaxel IV over 24 hours. Patients receive filgrastim (G-CSF) subcutaneously (SQ) daily beginning 24 hours after completion of paclitaxel infusion and continuing until blood counts recover and autologous peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells.

High dose chemotherapy and transplantation (3 weeks after PBSC harvest): Patients receive paclitaxel IV over 24 hours beginning on day 1, immediately followed by carboplatin IV over 2 hours, immediately followed by topotecan IV over 24 hours. Patients receive G-CSF sub-cutaneously (SQ) daily beginning 24 hours after completion of topotecan infusion and continuing until blood counts have recovered for 2 days. One quarter of the PBSC are reinfused beginning 2 days after completion of topotecan infusion. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with radiographic and biochemical complete response undergo laparoscopy as second look surgery within 8 weeks of the last course of chemotherapy. If no evidence of disease is found during laparoscopy, then exploratory laparotomy must also be performed.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or at time of recurrence until death.

Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida

    Given IV

  • FilgrastimBiological

    Also called Filgrastim XM02, G-CSF, Neupogen, r-metHuG-CSF

    Given SQ

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • Peripheral Blood Stem Cell TransplantationProcedure or surgery

    Also called PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplantation

    Undergo autologous peripheral blood stem cell transplantation

  • Topotecan HydrochlorideDrug

    Also called Hycamptamine, Hycamtin, SKF S-104864-A, Topotecan HCl

    Given IV

Study groups in NCT00004221
Study groupRoleWhat they receive
Treatment (Combination chemotherapy, PBSC)ExperimentalSee detailed description.
Receives: Drug: Carboplatin; Drug: Cyclophosphamide; Biological: Filgrastim; Drug: Paclitaxel; Procedure: Peripheral Blood Stem Cell Transplantation; Drug: Topotecan Hydrochloride

What is being measured

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

  1. Complete response defined as complete disappearance of all measurable and evaluable tumor documented at second-look surgery

    Measured: Up to 11 years

  2. Indication of excessive toxicity defined as hospitalization > 14 days per course, delay of day 1 therapy > 14 days, or grade 3 (irreversible) or grade 4 vital organ toxicity (non-hematologic)

    Measured: Up to 11 years

Secondary outcomes (2)

  1. Overall survival

    Measured: Up to 11 years

  2. PFS

    Measured: Up to 11 years

Timeline

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

  1. First posted25 Aug 2003 (estimated)
  2. Study startNov 1999
  3. Primary completion6 Feb 2002

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004221
Sponsor's protocol ID
GOG-9903
Other IDs
NCI-2012-02312, CDR0000067462, GOG-9903, GOG-9903, U10CA027469
Status last verified
Aug 2017
First submitted
28 Jan 2000
Last updated
9 Aug 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Cyclophosphamide and Filgrastim in people with Malignant Ovarian Mixed Epithelial Tumor and Ovarian Clear Cell Cystadenocarcinoma, run by Gynecologic Oncology Group 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?

The sponsor lists 42 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: stopped early, as of the sponsor's last update on 9 Aug 2017. 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 was stopped early. Results are not available in the source record.

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?

Complete response defined as complete disappearance of all measurable and evaluable tumor documented at second-look surgery (time frame: Up to 11 years). 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 NCT00004221.

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 9 Aug 2017.

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