Ovarian CancerPhase 1/2NCT00228319
Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants
A Phase 1/2 study testing Oral Ascorbic Acid, Paclitaxel and Carboplatin in people with Ovarian Cancer, run by Jeanne Drisko, MD, CNS, FACN at 1 site in United States.
Trial summary
The purpose of this study is to try and understand if there is added benefit or increased harm when antioxidant nutritional supplements are added to traditional chemotherapy in the treatment of ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Oral Ascorbic Acid, Paclitaxel and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Aug 2007
- Phase
- Phase 1/2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed carcinoma of the ovary stage III or IV
- measurable or assessable disease
- drug refractory ovarian cancer
- must be 18 years of age or must have parental consent to enroll in the study
- must be ambulatory
Who cannot join
- evidence of significant psychiatric disorder by history or exam
- consumption of excess alcohol (more than 4 of any of the following per day: 30 ml distilled spirits, 340 ml beer, or 120 ml wine) or recreational drugs
- tobacco use
- prior treatment with an investigational drug, chemo, radiation therapy, or hormonal therapy within the preceeding month
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Antioxidant Effects on the Outcome of Ovarian Cancer
The purpose of this study is to try and understand if there is added benefit or increased harm when antioxidant nutritional supplements are added to traditional chemotherapy in the treatment of ovarian cancer.
Read the detailed description
The subjects are randomized to 2 study groups. Group 1 receives standard chemotherapy prescribed by the cancer doctor (carboplatin and paclitaxel)with a possible choice to extend chemotherapy for up to an additional 12 months.
Group 2 receives standard chemotherapy in the same manner as group 1. In addition, they receive 12 months of oral or IV nutritional supplements.
- Conditions
- Ovarian Cancer
- Being tested
- Oral Ascorbic Acid, Paclitaxel, Carboplatin, Sodium Ascorbate, Oral Mixed natural Carotenoids with Vitamin A
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Ascorbic AcidDietary supplement
4 grams per day for 12 months
PaclitaxelDrug
Also called Taxol, Onxal
Six cycles
CarboplatinDrug
Also called Paraplatin
Six cycles
Sodium AscorbateDrug
Also called Vitamin C
Intravenous infusion at 0.5 gram/min twice weekly over 1-2 hours at a dose to achieve levels of 400 mg/dl for 12 months
Oral Mixed natural Carotenoids with Vitamin ADietary supplement
Capsule containing mixed carotenoids and vitamin A. Participant to take 1 daily for 12 months
Vitamin EDietary supplement
500 IU per capsule and participant to take 1 capsule daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Group | Active comparator | carboplatin and paclitaxel chemotherapy Receives: Drug: Paclitaxel; Drug: Carboplatin |
| Standar of Care + Ascorbic Acid Group | Experimental | carboplatin and paclitaxel chemotherapy, plus intravenous sodium ascorbate. In addition, participants will take a mix of vitamins including oral ascorbic acid, oral mixed natural carotenoids with vitamin A and oral vitamin E. Receives: Dietary Supplement: Oral Ascorbic Acid; Drug: Paclitaxel; Drug: Carboplatin; Drug: Sodium Ascorbate; Dietary Supplement: Oral Mixed natural Carotenoids with Vitamin A; Dietary Supplement: Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events by NCI CTC version 3.0
Measured: At each oncology clinic visit
Secondary outcomes (4)
Quality of Life Questionnaire
Measured: once a month for 6 months and the end of the study
Blood chemistry
Measured: At each oncology clinic visit
CA-125 analysis
Measured: At each oncology clinic visit
complete CBC with differential
Measured: At each oncology clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startOct 2002
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeanne Drisko, MD, CNS, FACN
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Treatment Research Foundation, University of Kansas Medical Center
- Responsible party
- Sponsor-investigator, Jeanne Drisko, MD, CNS, FACN, University of Kansas Medical Center
- Investigators
- Jeanne A. Drisko, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228319
- Sponsor's protocol ID
- 7823
- Other IDs
- G-01-029
- Status last verified
- Jun 2018
- First submitted
- 23 Sep 2005
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ma Y, Chapman J, Levine M, Polireddy K, Drisko J, Chen Q. High-dose parenteral ascorbate enhanced chemosensitivity of ovarian cancer and reduced toxicity of chemotherapy. Sci Transl Med. 2014 Feb 5;6(222):222ra18. doi: 10.1126/scitranslmed.3007154.
PubMed 24500406
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antioxidant Effects on the Outcome of Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00228319
- Acronym / sponsor ID
- 7823
- Conditions
- Ovarian Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Jeanne Drisko, MD, CNS, FACNUniversity, hospital or other
- Collaborators
- Cancer Treatment Research Foundation, University of Kansas Medical Center
- Study start
- Oct 2002
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 28 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to try and understand if there is added benefit or increased harm when antioxidant nutritional supplements are added to traditional chemotherapy in the treatment of ovarian cancer.
Detailed description
The subjects are randomized to 2 study groups. Group 1 receives standard chemotherapy prescribed by the cancer doctor (carboplatin and paclitaxel)with a possible choice to extend chemotherapy for up to an additional 12 months.
Group 2 receives standard chemotherapy in the same manner as group 1. In addition, they receive 12 months of oral or IV nutritional supplements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Group | Active comparator | Drug: Paclitaxel, Drug: Carboplatincarboplatin and paclitaxel chemotherapy |
| Standar of Care + Ascorbic Acid Group | Experimental | Dietary Supplement: Oral Ascorbic Acid, Drug: Paclitaxel, Drug: Carboplatin, Drug: Sodium Ascorbate, Dietary Supplement: Oral Mixed natural Carotenoids with Vitamin A, Dietary Supplement: Vitamin Ecarboplatin and paclitaxel chemotherapy, plus intravenous sodium ascorbate. In addition, participants will take a mix of vitamins including oral ascorbic acid, oral mixed natural carotenoids with vitamin A and oral vitamin E. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- histologically confirmed carcinoma of the ovary stage III or IV
- measurable or assessable disease
- drug refractory ovarian cancer
- must be 18 years of age or must have parental consent to enroll in the study
- must be ambulatory
Key exclusion criteria (5 listed)
- evidence of significant psychiatric disorder by history or exam
- consumption of excess alcohol (more than 4 of any of the following per day: 30 ml distilled spirits, 340 ml beer, or 120 ml wine) or recreational drugs
- tobacco use
- prior treatment with an investigational drug, chemo, radiation therapy, or hormonal therapy within the preceeding month
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Ascorbic Acid4 grams per day for 12 months | Dietary supplement | Standar of Care + Ascorbic Acid Group |
| PaclitaxelAlso: Taxol, OnxalSix cycles | Drug | Standar of Care + Ascorbic Acid Group, Standard of Care Group |
| CarboplatinAlso: ParaplatinSix cycles | Drug | Standar of Care + Ascorbic Acid Group, Standard of Care Group |
| Sodium AscorbateAlso: Vitamin CIntravenous infusion at 0.5 gram/min twice weekly over 1-2 hours at a dose to achieve levels of 400 mg/dl for 12 months | Drug | Standar of Care + Ascorbic Acid Group |
| Oral Mixed natural Carotenoids with Vitamin ACapsule containing mixed carotenoids and vitamin A. Participant to take 1 daily for 12 months | Dietary supplement | Standar of Care + Ascorbic Acid Group |
| Vitamin E500 IU per capsule and participant to take 1 capsule daily for 12 months | Dietary supplement | Standar of Care + Ascorbic Acid Group |
Primary outcome
Adverse events by NCI CTC version 3.0
Time frame: At each oncology clinic visit
4 secondary outcomes
Quality of Life Questionnaire
Time frame: once a month for 6 months and the end of the study
Blood chemistry
Time frame: At each oncology clinic visit
CA-125 analysis
Time frame: At each oncology clinic visit
complete CBC with differential
Time frame: At each oncology clinic visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Results publication: PubMed 24500406Ma Y, Chapman J, Levine M, Polireddy K, Drisko J, Chen Q. High-dose parenteral ascorbate enhanced chemosensitivity of ovarian cancer and reduced toxicity of chemotherapy. Sci Transl Med. 2014 Feb 5;6(222):222ra18. doi: 10.1126/scitranslmed.3007154.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne A. Drisko, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oral Ascorbic Acid, Paclitaxel and Carboplatin in people with Ovarian Cancer, run by Jeanne Drisko, MD, CNS, FACN at 1 site 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 5 inclusion and 5 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 19 Jun 2018. 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 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 combined 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.
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?
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?
Adverse events by NCI CTC version 3.0 (time frame: At each oncology clinic visit). 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 NCT00228319, which also lists 1 linked publication.
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 19 Jun 2018.