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Ovarian CancerPhase 2NCT04661696

Efficacy and Safety of Paclitaxel (Albumin-bound) Combination With Carboplatin in Ovarian Cancer.

A Phase 2 study testing Paclitaxel (albumin-bound) in people with Ovarian Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Epithelial ovarian cancer is the most fatal gynecological malignancy. Despite initial therapeutic response, the majority of advanced-stage patients relapse and eventually succumb to chemoresistant disease. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Paclitaxel (albumin-bound)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteChina
Study dates
9 Dec 2020to 23 Feb 2024
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age :18-75years old;
  • Histopathological confirmed epithelial ovarian cancer/fallopian tube/peritoneal cancer; Mucinous adenocarcinoma and low-grade serous carcinoma are excluded;
  • Recurrence more than 6 months after the last treatment with taxanes and platinum; Relapse ≤ 3 times; Recovered from the toxicity of the previous chemotherapy to ≤ 1 (hair loss ≤ 2);
  • Relapse confirmed by imaging and CA125:
  • Clinically evaluable recurrent lesions. According to the RECIST 1.1 , there is at least one measurable lesion as the target lesion. If the target lesion is a lymph node, the shorter diameter is required to be greater than 1.5 cm, and the target lesion has not received radiotherapy;
  • No clinically evaluable lesions:
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  • Adenocarcinoma cells are confirmed by cytology in the pleural and ascites; ii. Imaging considers that there is tumor recurrence, but the lesions do not meet the measurable standard. They are all small lesions (longest diameter <10 mm or pathological lymph node short diameter ≥10 mm to <15 mm). CA125 ≥ normal upper limit (ULN) 2 times, and CA125 is still showing an upward trend after rechecking after 1 week; c) Patients with recurrence can receive a second cytoreductive surgery. Postoperative R0 resection or residual tumor can be included in the group.
  • ECOG score 0-1;
  • Expected survival time ≥ 3 months;
  • Laboratory tests: absolute neutrophil count (ANC): ≥1.5×10^9/L； platelets (PLT)：≥100×10^9/L；hemoglobin (Hb): ≥90g/L (blood transfusions are allowed to meet or maintain the targets);
  • Liver and renal function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ULN 2.5times, or <ULN 5times in the presence of liver metastasis; total bilirubin (TBil) level≤ ULN 1.5 times or ≤ ULN 2.5 times when the patients have Gilbert's syndrome; Serum creatinine ≤ ULN 1.5 times or Calculated creatinine clearance ≥ 50 mL/min;
  • Must agree to use effective contraception during the trial; Women of childbearing potential must have a negative serum or urine pregnancy test; Non-lactating patients.
  • Signed the informed consent.

Who cannot join

  • Patients who had previously received paclitaxel (albumin-bound);
  • Patients who have received abdominal or pelvic radiotherapy;
  • Patients with central nervous system disease or brain metastases;
  • Other malignancies have occurred within the last 5 years, except for cured cervical carcinoma in situ, cutaneous squamous cell carcinoma or controlled basal cell carcinoma of the skin;
  • Prior Grade ≥ 2 sensory or motor neuropathy;
  • Uncontrolled serious medical conditions that, in the opinion of the investigator, would affect the ability of the subject to receive the study regimen, such as concomitant serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.
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  • Allergies to chemotherapeutic drugs or their excipients or intolerant patients;
  • Receive other anti-tumor drugs or participate in other anti-cancer treatment clinical studies within 4 weeks of the first chemotherapy administration;
  • Severe infections occurred within 4 weeks before treatment, including but not limited to infectious complications requiring hospitalization, bacteremia, or severe pneumonia;
  • Human immunodeficiency virus (HIV) positive;
  • Hepatitis B surface antigen (HBsAg) positive. For patients with previous HBV infection or HBV infection cured (the HBsAg is negative, but the total hepatitis B virus core antibody [HBcAb] is positive), if HBV DNA is negative or Undetectable, they can participate in this research;
  • Hepatitis C virus (HCV) antibody positive; Or human immunodeficiency virus and HCV RNA test both positive;
  • Researchers think it is not suitable for enrolling.

Trial locations and contacts

1 site in 1 country.

yangchun Sun contact

13661355755

yfc1303700@163.com

China1 site

  • National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100021

    yangchun Su, 13661355755, yfc1303700@163.com

Other trials in China

About this study

Official title: Efficacy and Safety of Paclitaxel (Albumin-bound) Combination With Carboplatin in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer: a Multicenter, Open, Phase 2 Clinical Study

Epithelial ovarian cancer is the most fatal gynecological malignancy. Despite initial therapeutic response, the majority of advanced-stage patients relapse and eventually succumb to chemoresistant disease. The majority of ovarian cancer patients with standardized treatment, including tumor cell reduction and postoperatively platinum-based combination chemotherapy, will still experience tumor recurrence and multiple recurrences within 6-18 months.With the increase in the number of recurrences, the intertherapeutic period will shorten and eventually drug resistance will emerge.The purpose of treatment for recurrent ovarian cancer is mainly to improve the quality of life of patients and prolong survival. CSPC OUYI PHARMACEUTICAL CO., LTD has successfully developed Paclitaxel (Albumin-Bound) and the bioequivalence test results show good consistency with Abraxane.To evaluate the efficacy and safety of Paclitaxel (Albumin-Bound) combination with carboplatin in Chinese patients with platinum-sensitive recurrent ovarian cancer, this clinical study is planned.

Read the detailed description

This study is a multicenter, open, single arm, phase 2 clinical study in patients with platinum-sensitive recurrent ovarian cancer.75 patients were planned to be enrolled, and the eligible patients were given the following regimen: Paclitaxel (Albumin-Bound) 130 mg/m^2, i.v., d1, d8;Carboplatin AUC 5, i.v.,d1;Every 21 days is a cycle, a total of 6 cycles.This study will be divided into three stages.The baseline period:Patients will complete screening tests at baseline to assess eligibility for inclusion criteria.Treatment period:(from the first dose to the last treatment cycle).Imaging tumor assessment was performed every 2 cycles (i.e. 6 weeks).Follow-up period:At the end of the study, patients were followed up by telephone or at the study center every 3 months to collect survival status and subsequent antitumor treatment until death or loss of follow-up.

Conditions
Ovarian Cancer
Being tested
Paclitaxel (albumin-bound)
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • Paclitaxel (albumin-bound)Drug

    Also called carboplatin

    The dose of intravenous chemotherapy drug is calculated according to the body surface area.When patients have serious adverse events, dose suspension and dose reduction are allowed. Paclitaxel (albumin-bound) was allowed to be reduced only twice (20% standard dose reduction in the first dose and 20% lower in the second dose).Once the dose is reduced, all subsequent doses should be maintained at reduced dosage.

Study groups in NCT04661696
Study groupRoleWhat they receive
single-armExperimentalPaclitaxel (albumin-bound) 130 mg/m2, i.v., d1, 8; Carboplatin AUC 5, i.v. d1; repeat every 21days, 6 cycles.
Receives: Drug: Paclitaxel (albumin-bound)

What is being measured

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

  1. Progression-free survival(PFS)

    From date of randomization until the date of first documented progression or died

    Measured: up to 36 months

Secondary outcomes (4)

  1. Objective response rate(ORR)

    The proportion of patients with tumor shrinkage reaching a certain amount and for a certain period of time, including cases of CR PR.

    Measured: up to 36 months

  2. Overall survival(OS)

    From date of randomization until the date of death from any cause

    Measured: up to 36 months

  3. disease control rate(DCR)

    including CR, PR, SD

    Measured: up to 36 months

  4. hematological toxicity and non-hematological toxicity

    including hematological toxicity and non-hematological toxicity

    Measured: up to 36 months

Timeline

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

  1. First posted10 Dec 2020
  2. Study start9 Dec 2020 (estimated)
  3. Primary completion23 Feb 2024 (estimated)
  4. Study completion23 Feb 2024 (estimated)

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
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04661696
Sponsor's protocol ID
19/339-2123
Status last verified
Dec 2020
First submitted
30 Nov 2020
Last updated
10 Dec 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel (albumin-bound) in people with Ovarian Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.

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 13 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 10 Dec 2020. 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 China. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact yangchun Sun (13661355755, yfc1303700@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival(PFS) (time frame: up to 36 months). 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 NCT04661696.

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 10 Dec 2020.

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