Cabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy.

NCT02560337 | Completed Phase 2 DMC

• 1 other identifier: CaTo-ROC
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Many ovarian cancer patients have been offered different standard cytostatics and gradually develop chemo-resistance. However, a considerable fraction of these patients are still in good general health and have a strong wish for further treatment. Cabazitaxel (Jevtana®) is a new taxane with effect in breast and prostatic cancer. In both tumors it has shown effect in patients refractory to docetaxel. Therefore, it could be anticipated that cabazitaxel may also have an effect in chemo-resistant ovarian cancer. The aim of the study is to investigate whether cabazitaxel could be a reasonable treatment option in patients with chemo-resistant and refractory ovarian cancer with regard to effect and toxicity.

Conditions

Ovarian Cancer

Keywords

Ovarian cancer; Relapse; Recurrence; Chemotherapy resistance

Outcome Measures

Primary Outcomes (1)

• Number of patients alive and without progression after three months of treatment

  3 months after start of treatment

Secondary Outcomes (3)

• Response rate

  Every 9 weeks from date of enrollment until the date of first documented progression or date of death of any cause, whichever came first. Assessed up to 24 months

• Progression free survival

  Every 9 weeks from date of enrollment until the date of first documented progression or date of death of any cause, whichever came first. Assessed up to 24 months

• Overall survival

  Every three months up to 24 months

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

25 mg/m2 administered as a one hour intravenous infusion on day 1 of a 3-week cycle. Treatment continues until progression or unacceptable toxicity.

Drug: Cabazitaxel

Interventions

Cabazitaxel DRUG

Also known as: Jevtana

Cabazitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
• Platinum resistant ovarian cancer with at least two previous cytostatic regimens or platinum-refractory disease defined as progression while receiving the last line of platinum based therapy or within 4 weeks of last platinum dose
• Progression on previous treatment.
• Measurable disease by RECIST 1.1 or evaluable by GCIG CA-125 criteria
• Age ≥ 18 years.
• Performance status 0-2.
• Neutrophils (ANC) ≥ 1.5 \* 10\^9/l
• Platelet count ≥ 100 \* 10\^9/l
• Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/l
• Serum bilirubin ≤ 1.0 \* ULN
• Serum transaminase ≤ 2.5 \* ULN
• Serum creatinine ≤ 1.5 ULN (at creatinine above 1.5 x ULN measured GFR must be at least 50 ml / min)
• Remaining life expectancy of at least 3 months
• Written informed consent

You may not qualify if:

• History of severe hypersensitivity reaction (≥grade 3) to taxol.
• History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs.
• Allergy to the active substance or any of the auxiliary agents.
• Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a 2-week wash-out period is necessary for patients who are already on these treatments)
• Neuropathy grade ≥ 2.
• Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
• Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment.
• Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
• History of any chronic medical or psychiatric condition or laboratory abnormality that is not medically controlled or in the opinion of the investigator may increase the risks associated with study drug administration. (e.g. diabetes, cardiac diseases, hypertension, renal, thyroid or liver disease).
• Vaccination with yellow fever vaccine or any live attenuated vaccine during the treatment.

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Vejle Hospital, Department of Oncology

Vejle, Denmark

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Recurrence

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karina D Steffensen

  Vejle Hospital, Department of Oncology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 25, 2015
• Study Start: September 1, 2015
• Primary Completion: December 5, 2018
• Study Completion: June 1, 2019
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

DK (1)