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Ovarian Papillary Serous CarcinomaPhase 1NCT02050009

Metformin Hydrochloride, Carboplatin, and Paclitaxel in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Phase 1 study testing metformin hydrochloride, carboplatin and paclitaxel in people with Ovarian Papillary Serous Carcinoma and Ovarian Serous Cystadenocarcinoma, run by Fox Chase Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase I trial studies the side effects and best way to give metformin hydrochloride, carboplatin, and paclitaxel in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
metformin hydrochloride, carboplatin and paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Start not givento 31 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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed high grade serous ovarian, fallopian tube or primary peritoneal cancer
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v.) 1.1; for those patients in the Phase 1a portion that are agreeable, disease must be amenable to ultrasound or computed tomography (CT) guided biopsy of a lesion outside of the target lesion; patients must have histologically or cytologically confirmed high grade serous ovarian, fallopian tube or primary peritoneal cancer
  • No antineoplastic therapy (eg, drugs, biologicals, monoclonal antibodies, etc) or radiotherapy within 6 months before enrollment; patients previously treated with antineoplastic therapy in the past must have recovered (ie, grade =< 1 toxicity or patient's baseline status, except alopecia) from all treatment-related toxicities
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Absolute neutrophil count >= 1,500 cells/mm^3
  • Platelets >= 100,000 cells/mm^3
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  • Hemoglobin >= 9 g/dL
  • Total bilirubin =< 1.5 times the upper limit of normal
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) (serum glutamic oxaloacetic transaminase [SGOT]/serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times institutional normal limits
  • Creatinine =< 1.5 for men and 1.4 for women
  • Fasting blood sugar =< 126
  • Hemoglobin A1C =< 6.5
  • Patients in the Phase 1a portion of the clinical trial must have a tumor that is deemed safe to biopsy and must consent to serial biopsies and or surgical resection after treatment with metformin
  • Patients must be minimally, status post bilateral salpingo-oophorectomy
  • Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document
  • Willing and able to comply with all appointments for treatment, lab testing, biopsies, imaging and any other testing
  • Suitable venous access for infusion of chemotherapy and phlebotomy

Who cannot join

  • Patients may not be receiving any other investigational agents
  • Patients must not have evidence of disease recurrence within 6 months of completing the last dose of platinum based therapy
  • Patient with current diagnosis of diabetes, or currently taking insulin, metformin, sulfonylureas, or other medications used for the treatment of elevated blood sugar
  • Conditions leading to increased risk of metformin induced lactic acidosis, including congestive heart failure (New York Heart Association [NYHA] class III or IV), history of acidosis, or daily intake of 3 or more alcoholic drinks
  • Use of metformin in the past 6 months
  • History of allergic reactions/hypersensitivity reactions to metformin
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  • History of allergic or hypersensitivity reaction to carboplatin, paclitaxel, or Cremophor® EL
  • Baseline nausea > grade 1
  • Baseline evidence of metabolic acidosis, with total carbon dioxide (TCO2) of less than 20
  • Patients with history of >= grade 2 neurotoxicity or any toxicity requiring discontinuation from taxanes chemotherapy that is not resolved to =< grade 1
  • Any condition that would prohibit patient from being able to take and digest metformin, such as gastroparesis, history of malabsorption, history of baseline diarrhea, current symptoms of small bowel obstruction, current symptoms of an ileus, history of a resection of the stomach or small bowel, or history of Crohn's disease/colitis
  • Current alcohol abuse: patients using more than 1 standard unit of alcohol per day for the past 30 days; a standard unit of alcohol is defined as a 12 oz beer (350 mL), 1.5 oz (45 mL) of 80-proof alcohol, or one 6-oz (175 mL) glass of wine
  • Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or breast feeding
  • Systemic infection requiring IV antibiotic therapy within 14 days preceding the first dose of metformin, or other severe infection
  • Diagnosis of or treated for another malignancy within 2 years of enrollment; patient with non-melanoma skin cancer or carcinoma in situ of any type, are not excluded if they have undergone complete resection; patients with a history of stage IA endometrial endometrioid carcinomas are also not excluded
  • Diagnosis of primary central nervous system (CNS) disease or carcinomatous meningitis
  • Patient has symptomatic brain metastasis; if patient has asymptomatic brain metastasis, must have:
  • Stable brain metastasis for 2 years documented radiographically.
  • Be without any neurological dysfunction that would confound evaluation of adverse events
  • Women of child-bearing potential (WOCBP) are not eligible for the study; since the standard of care for ovarian cancer treatment is total abdominal hysterectomy and bilateral salpingo-oophorectomy this is not thought to exclude patients who otherwise might want to participate

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

Other trials in United States

About this study

Official title: The Use and Safety of Metformin, Carboplatin and Paclitaxel in Non-Diabetic Patients With Recurrent, Platinum Sensitive Ovarian Cancer and the Feasibility of Using a Core Biopsy for RNA-Seq

This phase I trial studies the side effects and best way to give metformin hydrochloride, carboplatin, and paclitaxel in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as metformin hydrochloride, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the duration of response to metformin (metformin hydrochloride), carboplatin and paclitaxel followed by maintenance with metformin as compared to the primary duration of remission in within patient controls.

SECONDARY OBJECTIVES:

  1. Determine the in situ effects of metformin on lethal-7 (let-7) expression as determined by in situ hybridization. (Phase Ia) II. To determine the feasibility of using a core biopsy to perform ribonucleic acid (RNA) sequencing. (Phase Ia) III. To determine epigenomic effects of metformin via RNA-sequencing (Seq). (Phase Ia) IV. To determine the biologic effects of metformin through evaluation of pre and post metformin tumor samples for phosphorylated (p) adenosine monophosphate (AMP)-activated protein kinase (AMPK), v-myc myelocytomatosis viral oncogene homolog (avian) (myc), mechanistic target of rapamycin (mTOR) and phosphorylated v-akt Murine Thymoma Viral Oncogene Homolog 1 (pAKT). (Phase Ia) V. To assess safety and tolerability of metformin and carboplatin and paclitaxel in patients with platinum sensitive recurrent ovarian cancer. (Phase Ib)

OUTLINE:

Phase Ia: Patients receive metformin hydrochloride orally (PO) once daily (QD) on days 1-7 and twice daily (BID) on days 8-21.

Phase Ib: Patients receive metformin hydrochloride BID on days 1-21, paclitaxel intravenously (IV) over 3 hours on day 1, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 12 weeks.

Being tested
metformin hydrochloride, carboplatin, paclitaxel, laboratory biomarker analysis
Medical subject headings
Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

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

  • metformin hydrochlorideDrug

    Also called Glucophage

    Given PO

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

  • paclitaxelDrug

    Also called Anzatax, Asotax, TAX, Taxol

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT02050009
Study groupRoleWhat they receive
Treatment (metformin hydrochloride, carboplatin, paclitaxel)ExperimentalPatients receive metformin hydrochloride BID on days 1-21, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: metformin hydrochloride; Drug: carboplatin; Drug: paclitaxel; Other: laboratory biomarker analysis

What is being measured

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

  1. Probability of successes in patients receiving the combination therapy

    Success for a patient is defined as having a length of remission/progression free survival following this combination therapy that is longer than the length of remission/progression free survival resulting from their immediately prior line of treatment. A one-sided, one sample test of the binomial proportion will be conducted.

    Measured: Up to 2 years

Secondary outcomes (4)

  1. Time to progression

    Summarized using Kaplan-Meier methods.

    Measured: Time from first documentation of recurrence, to the first documentation of progression after initiating on this trial, assessed up to 2 years

  2. Response rate defined by the RECIST

    Computed along with 95% two-sided confidence intervals.

    Measured: Up to 2 years

  3. Progression free survival

    Summarized using Kaplan-Meier methods.

    Measured: Up to 4 years

  4. Overall survival

    Summarized using Kaplan-Meier methods.

    Measured: Up to 4 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 Jan 2014 (estimated)
  2. Primary completionOct 2014
  3. Study completion31 Oct 2014

Why it stopped: study was never opened to accrual

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02050009
Sponsor's protocol ID
GYN-062
Other IDs
NCI-2013-02223, IRB#13-033, GYN-062, P30CA006927
Status last verified
Feb 2019
First submitted
28 Jan 2014
Last updated
20 Feb 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing metformin hydrochloride, carboplatin and paclitaxel in people with Ovarian Papillary Serous Carcinoma and Ovarian Serous Cystadenocarcinoma, 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?

The sponsor lists 17 inclusion and 21 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: withdrawn, as of the sponsor's last update on 20 Feb 2019. 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 was withdrawn before enrolling participants, so there are no results.

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?

Probability of successes in patients receiving the combination therapy (time frame: Up to 2 years). 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 NCT02050009.

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 20 Feb 2019.

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