Health TrialsbyHealthPanel

Combination Therapy for Recurrent Ovarian Cancer

ConditionRecurrent Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSham Sunder Kakar

About this trial

The proposed study "combination therapy with liposomal doxorubicin and withaferin A (Ashwagandha, ASWD) in recurrent ovarian cancer" is focused to determine the feasibility and maximum tolerance dose of Ashwagandha with liposomal doxorubicin (DOXIL) in recurrent ovarian cancer patients. The study contains two parts. In part 1 (phase I), 18 patients with recurrent ovarian cancer eligible for DOXIL therapy will be recruited and three doses of Ashwagandha (2.0 g, 4.0 g and 8.0 g) in the form of tablets along with DOXIL will be evaluated for feasibility and tolerance of ASWD. In part 2 (phase II), 54 patients with recurrent ovarian cancer will be recruited and treated with DOXIL and Ashwagandha (dose determined from part 1) to evaluate the complete response (CR), partial response (PR), and stable disease (SD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed approved informed consent document stating that they understand the investigational nature of the treatment program before entering study

Female patients, age ≥ 18 years

Pathological confirmed ovarian, fallopian tube, or primary peritoneal carcinoma with the one of the following histologic types: high grade papillary serous carcinoma, low grade papillary serous carcinoma, high grade mucinous carcinoma, low grade mucinous carcinoma, clear cell carcinoma, high grade endometrioid carcinoma.

Received at least one line chemotherapy, which must be a platinum containing regimen and develop platinum resistance. Patients may have not received previous liposomal doxorubicin therapy, and must be considered to be eligible for single agent liposomal doxorubicin treatment.

Disqualifiers

ECOG performance status 3 or 4

Pregnant or breastfeeding

Treatment with another investigational drug, biological agent, or device within 4 weeks (6 weeks for biological agents) before screening or 5 half-lives of study agent, whichever is longer

Patients with treated or untreated parenchymal brain metastases or leptomeningeal disease. Brain imaging is required for symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients

Trial design

Design model

Single group

Treatments tested in this trial

  • DOXIL

    Drug

    DOXIL will be administered IV as 40 mg/m2 IV every four weeks for 4 cycles or until disease progression and/or unacceptable toxicity, whichever comes first to a maximum of 10 cycles.

  • Withaferin A

    Drug

    Ashwagandha in the form of tablets will be administered orally on daily basis.

  • Ashwagandha

    Drug

    Administered orally on daily basis twice a day

  • Combination of ASWD and DOXIL

    Drug

    DOXIL administered IV once every four weeks. ASWD administered orally on daily basis, twice a day.

Treatment groups

72 Participants
are divided into 1 treatment group
Group A: Combination of DOXIL and AshwagandhaExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

Will be presented by Kaplan Meier methods.

Time frame
From study entry to time of progression or death, whichever occurs first, assessed up to 4 years.

Secondary outcomes

1

Incidence of adverse events (AE)

All adverse events, including severe adverse events and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Time frame
From study entry, up to 4 years.
2

Objective response rate (ORR)

Quantified as the binomial proportion of patients with measurable disease at enrollment who have a best overall response of complete response (CR) or partial response (PR).

Time frame
From the start of the treatment until disease progression/recurrence, assessed up to 4 years
3

Duration of response

Will be defined among participants with the best overall response of complete response (CR) or partial response (PR). Will be presented by Kaplan Meier methods.

Time frame
From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 4 years.
4

Overall survival

Will be presented by Kaplan Meier methods.

Time frame
Time from study entry to date of death from any cause, assessed up to 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sham Sunder Kakar

Lead sponsor

University of Louisville

Sponsor institution

University of Louisville

Collaborator

Source ClinicalTrials.gov
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