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Ovarian CancerPhase 1NCT02121990

Dose-Escalation Study of Intraperitoneal (IP) Cisplatin, IV/IP Paclitaxel, IV Bevacizumab, and Oral Olaparib for Newly Diagnosed Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

A Phase 1 study testing Paclitaxel,, Bevacizumab and Cisplatin in people with Ovarian Cancer and Primary Peritoneal Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites 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 study is to test the safety of the drug olaparib at different dose levels. It will be given with the standard initial chemotherapy for cancer as well as a drug called bevacizumab. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Paclitaxel,, Bevacizumab and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
5 sitesUnited States
Study dates
21 Apr 2014to 19 Aug 2020
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

  • Subjects with histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma, following initial surgery. All subjects must have had appropriate surgery for ovarian, primary peritoneal, or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage. Pathology must be verified at Memorial Sloan-Kettering Cancer Center. Patients with initial cytoreduction surgery performed at outside hospitals will be eligible for this protocol.
  • Patients with the following histologic cell types are eligible:
  • High grade serous adenocarcinoma
  • Endometrioid adenocarcinoma
  • Undifferentiated carcinoma
  • Clear cell adenocarcinoma
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  • Mixed epithelial adenocarcinoma
  • Adenocarcinoma not otherwise specified (N.O.S.)
  • Carcinosarcoma
  • Subjects must have a Karnofsky Performance Status (KPS) of ≥ 70%.
  • Subjects must be entered no more than 12 weeks postoperatively.
  • Subjects must agree to undergo genetic counseling and BRCA testing. Patients in the expansion cohort must have a germline BRCA 1 or 2 mutation.
  • Physical and Laboratory Test Findings
  • PT such that international normalized ratio (INR) is ≤1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a PTT ≤ 1.5 times the upper limit of normal.
  • Bone marrow function:
  • Absolute neutrophil count (ANC) ≥ 1,500/mcL
  • Platelets ≥ 100,000/mcL
  • Renal function:
  • Creatinine ≤ 1.5 mg/dl
  • Hepatic function:
  • Bilirubin ≤ 1.5 x ULN
  • AST and ALT ≤ 3 x ULN
  • Neurologic function:
  • Neuropathy (sensory) ≤ CTC Grade 1
  • Urine Protein Creatinine:
  • Urine protein creatinine (UPC) ratio must be < 1.0 gm.
  • If UPC ratio ≥1, collection of 24-hour urine measurement of urine protein is recommended *
  • UPC ratio of spot urine is an estimation of the 24 urine protein excretion - a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm. UPC ratio is calculated using one of the following formulas:
  • [urine protein]/[urine creatinine] - if both protein and creatinine are reported in mg/dL
  • [(urine protein) x0.088]/[urine creatinine] - if urine creatinine is reported in mmol/L *The UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection. Specifically, a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24 hour urine collection. Obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24 hour urine). Send sample to lab with request for urine protein and creatinine levels [separate requests]. The lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL). The UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL). Patients must have a UPCR < 1.0 to allow participation in the study.
  • Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception during the study and for at least 6 months after receiving the final treatment of bevacizumab.
  • Patients must have an Intraperitoneal (IP) port in place. If a patient does not have an IP port, she must be willing to undergo surgical placement of one.

Who cannot join

  • Subjects with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible.
  • Patients with synchronous primary endometrial cancer or a past history of endometrial cancer, unless all of the following conditions are met:
  • Stage not greater than IB
  • No more than superficial myometrial invasion
  • No vascular or lymphatic invasion
  • No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO Grade 3 lesions.
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  • Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior intravaginal brachytherapy is permitted. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 3 years prior to enrollment, and the subject remains free of recurrent or metastatic disease.
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients who have received neoadjuvant chemotherapy prior to their initial debulking are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer.
  • With the exception of non-melanoma skin cancer and other specific malignancies as noted above, subjects with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 3 years or whose previous cancer treatment contraindicates this protocol therapy are excluded.
  • Patients who have received prior bevacizumab (or any other VEGF targeted agent) or prior PARP inhibitor.
  • Subjects with acute hepatitis.
  • Subjects with active infection that requires parenteral antibiotics.
  • > Grade 1 hearing loss or tinnitus
  • Patients who are pregnant or nursing.
  • Patients under the age of 18.
  • Patients with clinical symptoms or signs of gastrointestinal obstruction, require parenteral hydration or nutrition, require a drainage gastrostomy tube and/or have any other impairment that limits their ability to take oral medication.
  • Patients with serious non-healing wound, ulcer, or bone fracture including history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days. Patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations.
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
  • Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.
  • Patients with clinically significant cardiovascular disease including
  • Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg.
  • Myocardial infarction or unstable angina < 6 months prior to registration.
  • New York Heart Association (NYHA) Class II or higher congestive heart failure
  • Serious cardiac arrhythmia requiring medication.
  • CTEP CTCAE Version 4.0, Grade 2 or higher peripheral ischemia [brief (<24 hrs) episode of ischemia managed non-surgically and without permanent deficit].
  • Core biopsy or other minor surgical procedure (excluding placement of a vascular access device, paracentesis, and/or thoracentesis) within 7 days prior to the first date of bevacizumab therapy.
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
  • Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4. Lists including medications or substances known or with the potential to interact with these enzymes.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Memorial Sloan Kettering Cancer Center at Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Cancer Center at Mercy Medical Center

    Rockville Centre, New York, 11570

Other trials in United States

About this study

Official title: A Phase 1 Dose-Escalation Study of Intraperitoneal (IP) Cisplatin, IV/IP Paclitaxel, IV Bevacizumab, and Oral Olaparib for Newly Diagnosed Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

The purpose of this study is to test the safety of the drug olaparib at different dose levels. It will be given with the standard initial chemotherapy for cancer as well as a drug called bevacizumab.

Keywords
(IP) Cisplatin, IV/IP Paclitaxel, IV Bevacizumab, Oral Olaparib (AZD2281), Optimally Debulked, Stage II/III, Ovary, Pertoneum, 10-220
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

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

Study groups in NCT02121990
Study groupRoleWhat they receive
Cisplatin, Paclitaxel, bevacizumab & olaparibExperimentalAll treatments will be given in the outpatient setting. A cycle is 21 days. The sequence of infusions on Day 1 will be IV paclitaxel (135 mg/m2), then IV bevacizumab (15 mg/kg, beginning Cycle 2). On Day 2 patients will receive IP cisplatin (75 mg/m2). Patients will be given twice-daily treatment with oral olaparib in cycles 1-6 for 7 consecutive days, starting on Day 2 (Days 2-8). IP paclitaxel (60 mg/m2) will be given on Day 8. Sequential cohorts of 3 patients will receive escalating doses of olaparib (50mg BID, 100mg BID, 200mg BID).
Receives: Drug: Paclitaxel,; Drug: Bevacizumab; Drug: Cisplatin; Drug: Olaparib

What is being measured

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

  1. maximum tolerated dose (MTD)

    This is a dose-finding Phase 1 study, which employs a 3+3 design, and aims to identify the MTD of a combination of traditional and novel agents for front-line therapy of optimally debulked ovarian cancer.

    Measured: 1 year

Secondary outcomes (1)

  1. Toxicity

    assessed in accordance with the CTCAE Version 4.0

    Measured: 1 year

Timeline

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

  1. First posted24 Apr 2014 (estimated)
  2. Study start21 Apr 2014
  3. Primary completion19 Aug 2020
  4. Study completion19 Aug 2020

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02121990
Sponsor's protocol ID
10-220
Status last verified
Aug 2020
First submitted
22 Apr 2014
Last updated
21 Aug 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Paclitaxel,, Bevacizumab and Cisplatin in people with Ovarian Cancer and Primary Peritoneal Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites 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 32 inclusion and 28 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 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

maximum tolerated dose (MTD) (time frame: 1 year). 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 NCT02121990.

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 21 Aug 2020.

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