Cabazitaxel vs. Tocotrienol in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy. (CaTo-ROC)

• ClinicalTrials.gov Identifier: NCT02560337
• Recruitment Status: Completed
• First Posted: September 25, 2015
• Last Update Posted: September 4, 2019
• Sponsor: Vejle Hospital
• Information provided by (Responsible Party): Vejle Hospital

Study Description

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.

Tocotrienol is a fraction of the natural E-vitamin with several biological effects, including effect on malignant cells and angiogenesis.

The aim of the study is to investigate whether cabazitaxel and tocotrienol could be reasonable treatment options in patients with chemo-resistant and refractory ovarian cancer with regard to effect and toxicity.

In case of progression on cabazitaxel there is an option of crossing over to tocotrienol and vice versa.

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer	Drug: Cabazitaxel; Drug: Tocotrienol	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cabazitaxel vs. Tocotrienol in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy - A Phase 2 Randomized, Open-label Study
• Actual Study Start Date: September 2015
• Actual Primary Completion Date: December 5, 2018
• Actual Study Completion Date: June 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cabazitaxel; 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. On progression there is an option of crossing over to tocotrienol.	Drug: Cabazitaxel; Other Name: Jevtana
Experimental: Tocotrienol; 900 mg (300 mg x 3 every day) until progression or unacceptable toxicity. On progression there is an option of crossing over to cabazitaxel.	Drug: Tocotrienol

Outcome Measures

Primary Outcome Measures :

1. Number of patients alive and without progression after three months of treatment with cabazitaxel or tocotrienol. [ Time Frame: 3 months after start of treatment ]

Secondary Outcome Measures :

1. Response rate [ Time Frame: Every 9 weeks from date of randomization until the date of first documented progression or date of death of any cause, whichever came first. Assessed up to 24 months ]
2. Progression free survival [ Time Frame: Every 9 weeks from date of randomization until the date of first documented progression or date of death of any cause, whichever came first. Assessed up to 24 months ]
3. Overall survival [ Time Frame: Every three months up to 24 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

• Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):

  • 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

Exclusion Criteria:

• 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 malignant diseases within 5 years prior to inclusion in the study, except basal cell or squamous cell carcinoma of the skin and cervical carcinoma-in-situ.
• 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.

Contacts and Locations

Locations

Denmark

Vejle Hospital, Department of Oncology

Vejle, Denmark

Sponsors and Collaborators

Vejle Hospital

Investigators

• Study Chair: Karina D Steffensen; Vejle Hospital, Department of Oncology

More Information

• Responsible Party: Vejle Hospital
• ClinicalTrials.gov Identifier: NCT02560337
• Other Study ID Numbers: CaTo-ROC
• First Posted: September 25, 2015
• Last Update Posted: September 4, 2019
• Last Verified: September 2019

Keywords provided by Vejle Hospital:

Ovarian cancer; Relapse; Recurrence; Chemotherapy resistance

Additional relevant MeSH terms:

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Tocotrienols; Vitamin E; Tocopherols; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs; Vitamins; Micronutrients; Nutrients; Growth Substances