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Leydig Cell TumorPhase 1NCT01652794

Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer

A Phase 1 study testing stereotactic body radiation therapy, carboplatin and gemcitabine hydrochloride in people with Leydig Cell Tumor and Ovarian Sarcoma, run by Case Comprehensive Cancer Center at 1 site in United States.

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

The purpose of this phase I study is to determine the highest dose of carboplatin and gemcitabine (gemcitabine hydrochloride) that can be given safely to subjects with gynecologic cancer, in combination with stereotactic body radiation therapy (SBRT). This dose is called the maximum tolerated dose (MTD). Read more about this study

Who is it for?
Ages 19 years and older, women only
What is being tested?
stereotactic body radiation therapy, carboplatin and gemcitabine hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
May 2012to Mar 2015
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 19 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient has diagnosis of a persistent or recurrent gynecologic cancer
  • Patient age is > 18 years.
  • Patient must have at least one abdominopelvic measurable site of disease as defined by 9.1.3;. A treatment planning 18F-FDG positron emission tomography and computed tomography scan (PET/CT; whole body) may be used to complement assessment, \& if done must be completed prior to first dose of carboplatin / gemcitabine and within 35 days of first day of SBRT. There MUST BE no more than four (4) intended radiosurgical target lesions. An individual (one of up to four) radiosurgical target lesion MUST NOT EXCEED a volume of no greater than 160 cubic centimeters (cc).
  • No prior cryosurgery or radiofrequency ablation in SBRT-target lesion. Patients with prior cryoablation and radiofrequency ablation are excluded as these treatments are designed to destroy tissue with freezing or heat. Radiation treatments given by SBRT may not work biologically or may cause excessive tissue injury in patients who have had prior cryoablation and radiofrequency ablation.
  • Patient has no major medical illnesses or psychiatric illnesses:
  • New York Heart Association (NYHA) class 3 or 4 congestive heart failure;
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  • unstable angina pectoris;
  • symptomatic cardiac arrhythmia;
  • hypertension with diastolic blood pressure greater than 110 mmHg;
  • pulmonary disease consisting of dyspnea at rest requiring oxygen supplementation;
  • renal function impairment (defined here as baseline serum creatinine >2.0 mg/dL);
  • psychiatric illness/social situations that would limit compliance.
  • Patient must have no known brain metastases. These patients are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound neurological and other adverse event evaluation.
  • Patient must demonstrate adequate organ function (< 35 days from enrollment):
  • Bone marrow: absolute neutrophil count (ANC) ≥ 1500/mcl, platelets ≥ 100,000, hemoglobin ≥ 10 mg/dL.
  • Renal function: creatinine ≤ 2.0 mg/dL.
  • Hepatic function: bilirubin ≤ 1.5X institutional upper limit of normal (ULN); AST, ALT, alkaline phosphatase ≤ 2.5X ULN
  • Patient MUST have had prior chemotherapy or radiation for a gynecologic cancer. Patient is > 28 days from previous treatment (chemotherapy or radiation) and toxicities related to the previous treatment must have resolved to grade 1 or baseline.
  • Patient has Gynecologic Oncology Group performance status score of 0 or 1.
  • Patient is able to give study-specific informed consent

Who cannot join

  • Any patient NOT meeting the above criteria
  • Any patient with active connective tissue disease such as lupus or dermatomyositis is excluded; patients with active connective tissue disease are at an excessive risk of organ function-impairing fibrosis
  • Any patient with active Crohn's disease or active ulcerative colitis is excluded; patients having these conditions are at an excessive risk of organ function-impairing fibrosis
  • Any patient with known anaphylaxis to carboplatin or gemcitabine is excluded
  • Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects; screening beta-human chorionic gonadotropin (hcg) levels (urine or blood) and diagnostic tests will be used to determine eligibility in women of childbearing potential; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; these potential risks may also apply to carboplatin/gemcitabine chemotherapy agents used in this study
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with carboplatin or gemcitabine; in addition, patients known to be HIV-positive patient are excluded due to an increased risk of lethal infections when treated with marrow-suppressive therapy such as carboplatin/gemcitabine; HIV testing is not mandatory for eligibility evaluation
  • Due to a perceived increased risk to transplanted organ for lethal dysfunction or lethal infection, patients with visceral organ transplants are not eligible
  • Patients with other active non-gynecologic invasive malignancies are excluded; patients with other invasive malignancies who had (or have) cancer present within the last two years are excluded

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: A Phase 1 Study of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Body Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer

The purpose of this phase I study is to determine the highest dose of carboplatin and gemcitabine (gemcitabine hydrochloride) that can be given safely to subjects with gynecologic cancer, in combination with stereotactic body radiation therapy (SBRT). This dose is called the maximum tolerated dose (MTD). To determine the MTD, patients will receive different amounts of carboplatin and gemcitabine.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine maximum tolerated carboplatin/gemcitabine dose administered with SBRT as measured by < 30-day acute toxicity defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

SECONDARY OBJECTIVES:

  1. Off-study SBRT target local control assessment: 6-week post-trial fludeoxyglucose F 18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) or other imaging response by European Organisation for Research and Treatment of Cancer (EORTC) PET criteria as listed and National Cancer Institute (NCI) guidelines.

II. Off-treatment late toxicity assessment: record 3-month and 6-month radiation-related toxicity defined by CTCAE v4.0.

III. Off-study global clinical benefit assessment: 6-month post-therapy clinical benefit (defined as percentage of patients who had complete, partial, or stable disease for at least 6 months).

TERTIARY OBJECTIVES:

  1. Associate pretherapy tumor biopsy ribonucleotide reductase (R1, R2, p53R2), Tip60 and Poly(ADP-ribose) polymerase 1/2 expression with 6-week therapy response.

OUTLINE: This is a dose-escalation study of carboplatin and gemcitabine hydrochloride.

Patients also receive carboplatin intravenously (IV) over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on day 1 and undergo SBRT on days 2-4.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year, and then yearly for 2 years.

Being tested
stereotactic body radiation therapy, carboplatin, gemcitabine hydrochloride, laboratory biomarker analysis, pharmacogenomic studies
Medical subject headings
Leydig Cell Tumor, Pseudomyxoma Peritonei, Uterine Cervical Neoplasms, Endometrial Neoplasms, Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial, Vaginal Neoplasms, Vulvar Neoplasms

What participants receive

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

  • stereotactic body radiation therapyRadiation

    Also called SBRT, stereotactic radiation therapy, stereotactic radiotherapy

    Undergo SBRT

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

  • gemcitabine hydrochlorideDrug

    Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

    Given IV

  • laboratory biomarker analysisOther

    Optional correlative studies

  • pharmacogenomic studiesOther

    Also called Pharmacogenomic Study

    Optional correlative studies

Study groups in NCT01652794
Study groupRoleWhat they receive
Treatment (carboplatin, gemcitabine hydrochloride, and SBRT)ExperimentalPatients also receive carboplatin IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on day 1 and undergo SBRT on days 2-4.
Receives: Radiation: stereotactic body radiation therapy; Drug: carboplatin; Drug: gemcitabine hydrochloride; Other: laboratory biomarker analysis; Other: pharmacogenomic studies

What is being measured

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

  1. Rate of acute grade 3-5 toxicities following carboplatin/gemcitabine hydrochloride and SBRT treatment graded based on CTCAE, version 4.0

    A modified Fibonacci design used during the dose-finding portion of this study. When =< 1 out of 6 patients enter at highest next dose level below the maximum tolerated dose (MTD), this is the recommended phase 2 dose. At least 6 patients must be entered at the recommended phase 2 dose.

    Measured: Within 30 days of completing treatment

Secondary outcomes (2)

  1. Progression-free survival

    Calculated following the method of Kaplan and Meier and survival dependence on measured covariates will be assessed using the Cox proportional hazards model.

    Measured: From the time from registration until time of progression, recurrence, or death, up to 6 months

  2. Survival dependence on measured covariates

    Descriptive and tabular data will be reported. Assessed using the Cox proportional hazards model.

    Measured: Up to 5 years

Timeline

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

  1. First posted30 Jul 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionMay 2014
  4. Study completionMar 2015

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01652794
Sponsor's protocol ID
CASE8810
Other IDs
NCI-2012-00608
Status last verified
Aug 2015
First submitted
26 Jul 2012
Last updated
4 Aug 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing stereotactic body radiation therapy, carboplatin and gemcitabine hydrochloride in people with Leydig Cell Tumor and Ovarian Sarcoma, run by Case Comprehensive 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?

The sponsor lists 20 inclusion and 8 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 4 Aug 2015. 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 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?

Rate of acute grade 3-5 toxicities following carboplatin/gemcitabine hydrochloride and SBRT treatment graded based on CTCAE, version 4.0 (time frame: Within 30 days of completing treatment). 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 NCT01652794.

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 4 Aug 2015.

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