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Ovarian CancerPhase 2NCT00003892

ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer

A Phase 2 study testing ISIS 5132 in people with Ovarian Cancer, run by NCIC Clinical Trials Group at 66 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ISIS 5132 in treating patients who have metastatic or recurrent ovarian cancer that has not responded to previous chemotherapy. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
ISIS 5132
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
66 sitesin 3 countries
Study dates
1 Feb 1999to 22 Sep 2008
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 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS: Histologically documented ovarian epithelial cancer Metastatic and/or locally recurrent disease that is incurable with standard therapy Must have received 1 or 2 prior regimens of chemotherapy At least 1 regimen must have contained cisplatin or carboplatin Bidimensionally measurable disease Indicator lesion size must be as follows: At least 4-50 cm2 by CT scan At least 1 cm2 by chest xray At least 1 cm2 (e.g., nodules) by physical exam No abdominal adenocarcinoma of unknown origin No borderline ovarian tumor No tumor known to be of primary fallopian tube or peritoneal origin

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 No known bleeding disorder Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST less than 5 times ULN PT/PTT normal (except when elevated due to therapeutic coumadin) Renal: Creatinine no greater than 2 times ULN Cardiovascular: No significant cardiac dysfunction Neurologic No history of significant neurologic disorder No significant psychiatric disorder Other: Not pregnant or nursing Fertile patients must use effective contraception At least 5 years since prior malignancy and no evidence of recurrence No other serious illness or medical condition No active uncontrolled infection No complete bowel obstruction

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No other concurrent cytotoxic therapy Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy At least 4 weeks since radiotherapy to at least 20% of bone marrow Surgery: Not specified Other: As least 28 days since prior investigational agent or new anticancer therapy No concurrent therapeutic heparin No other concurrent investigational therapy

Trial locations and contacts

66 sites in 3 countries.

66 sites in 3 countries

Canada63 sites

  • Royal Victoria Hospital, Barrie

    Barrie, Ontario, L4M 6M2

  • Peel Memorial Hospital

    Brampton, Ontario, L6W 2Z8

  • Burnaby Hospital Regional Cancer Centre

    Burnaby, British Columbia, V5H 4C2

  • Queen Elizabeth Hospital, PEI

    Charlottetown, Prince Edward Island, C1A 8T5

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Centre Universitaire de Sante de l'Estrie

    Fleurimont, Quebec, J1H 5N4

  • Northeastern Ontario Regional Cancer Centre, Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Queen Elizabeth II Health Science Center

    Halifax, Nova Scotia, B3H 2Y9

  • Cancer Care Ontario-Hamilton Regional Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Centre Hospitalier Regional de Lanaudiere

    Joliette, Quebec, J6E 6J2

  • Kingston Regional Cancer Centre

    Kingston, Ontario, K7L 5P9

  • Lethbridge Cancer Clinic

    Lethbridge, Alberta, T1J 1W5

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Trillium Health Centre

    Mississauga, Ontario, L5B 1B8

  • Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • Moncton Hospital

    Moncton, New Brunswick, E1C 6ZB

  • Doctor Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

  • Hotel Dieu de Montreal

    Montreal, Quebec, H2W 1T8

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2W-W1T8

  • Centre Hospitalier de l'Universite' de Montreal - Pavillon Saint-Luc, Montreal

    Montreal, Quebec, H2X 3J4

  • Royal Victoria Hospital - Montreal

    Montreal, Quebec, H3A 1A1

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • St. Mary's Hospital Center

    Montreal, Quebec, H3T 1M5

  • Queen Elizabeth Hospital, Montreal

    Montreal, Quebec, H4A 3L6

  • Hopital Du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • York County Hospital

    Newmarket, Ontario, L3Y 2P9

  • North York General Hospital, Ontario

    North York, Ontario, M2E 1K1

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • Ottawa Regional Cancer Center - General Division

    Ottawa, Ontario, K1H 8L6

  • Ottawa Regional Cancer Centre - Civic Campus

    Ottawa, Ontario, K1Y 4K7

  • Penticton Regional Hospital

    Penticton, British Columbia, V2A 3G6

  • Peterborough Oncology Clinic

    Peterborough, Ontario, K9H 7B6

  • Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec

    Québec, Quebec, G1R 2J6

  • Hopital du Saint-Sacrament, Quebec

    Québec, Quebec, G1S 4L8

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Hopital du Haut-Richelieu

    Saint-Jean-sur-Richelieu, Quebec, J3A 1B7

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Algoma District Medical Group

    Sault Ste. Marie, Ontario, P6B 1Y5

  • Scarborough Hospital - General Site

    Scarborough Village, Ontario, M1P 2V5

  • Hotel Dieu Hospital - St. Catharines

    St. Catharines, Ontario, L2R 5K3

  • Dr. H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Hopital Laval

    Ste-Foy, Quebec, G1V 4G5

  • British Columbia Cancer Agency - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Northwestern Ontario Regional Cancer Centre, Thunder Bay

    Thunder Bay, Ontario, P7A 7T1

  • Toronto East General Hospital

    Toronto, Ontario, M4C 3E9

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital - Toronto

    Toronto, Ontario, M5B 1W8

  • Mount Sinai Hospital - Toronto

    Toronto, Ontario, M5G 1X5

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Women's College Campus, Sunnybrook and Women's College Health Science Center

    Toronto, Ontario, M5S 1B6

  • Saint Joseph's Health Centre - Toronto

    Toronto, Ontario, M6R 1B5

  • Prostate Centre at Vancouver General Hospital

    Vancouver, British Columbia, V5Z 3J5

  • BC Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

  • St. Paul's Hospital - Vancouver

    Vancouver, British Columbia, V6Z 1Y6

  • British Columbia Cancer Agency - Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 1J8

  • Humber River Regional Hospital

    Weston, Ontario, M9N 1N8

  • Cancer Care Ontario - Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

United States2 sites

  • Duluth Clinic

    Duluth, Minnesota, 55805

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

United Kingdom1 site

  • Royal South Hants Hospital

    Southampton, England, SO14 0YG

Other trials in United Kingdom

About this study

Official title: Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of ISIS 5132 in treating patients who have metastatic or recurrent ovarian cancer that has not responded to previous chemotherapy.

Read the detailed description

OBJECTIVES: I. Determine the efficacy of ISIS 5132 by evaluating objective response and duration of response in patients with recurrent ovarian epithelial cancer. II. Determine the tolerability and quantitative toxicity of ISIS 5132 in this patient population.

OUTLINE: This is a multicenter study. Patients receive ISIS 5132 IV continuously for 21 days. Courses are repeated every 28 days. Treatment continues for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. Patients with documented complete response receive an additional 2 courses. Patients with documented partial response receive an additional 4 courses. Patients are followed at 4 weeks, then every 3 months until disease relapse or progression.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study over 12-15 months.

Conditions
Ovarian Cancer
Being tested
ISIS 5132
Keywords
stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

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

  • ISIS 5132Drug

    4mg/kg/day IV for 21 days every 4 weeks.

Study groups in NCT00003892
Study groupRoleWhat they receive
ISIS 5132ExperimentalISIS 5132 x 21 days IV infusion
Receives: Drug: ISIS 5132

What is being measured

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

  1. Objective and duration of response

    To determine the efficacy of ISIS 5132 in patients with recurrent epithelial ovarian cancer, with evaluation of objective responses and duration of responses in patients receiving this compound in a phase II trial.

    Measured: 9 years

Secondary outcomes (1)

  1. Toxicity

    To determine the tolerability and quantitative toxicity of ISIS 5132 when given to patients with recurrent ovarian cancer

    Measured: 9 years

Timeline

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

  1. First posted5 Aug 2004 (estimated)
  2. Study start1 Feb 1999
  3. Primary completion17 Oct 2000
  4. Study completion22 Sep 2008

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003892
Sponsor's protocol ID
I116
Other IDs
CAN-NCIC-IND116, CDR0000067061
Status last verified
Apr 2020
First submitted
1 Nov 1999
Last updated
6 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Oza AM, Elit L, Swenerton K, Faught W, Ghatage P, Carey M, McIntosh L, Dorr A, Holmlund JT, Eisenhauer E; NCIC Clinical Trials Group Study (NCIC IND.116). Phase II study of CGP 69846A (ISIS 5132) in recurrent epithelial ovarian cancer: an NCIC clinical trials group study (NCIC IND.116). Gynecol Oncol. 2003 Apr;89(1):129-33. doi: 10.1016/s0090-8258(02)00144-0.

    PubMed 12694666

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ISIS 5132 in people with Ovarian Cancer, run by NCIC Clinical Trials Group at 66 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in Canada, United States, United Kingdom. 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?

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?

Objective and duration of response (time frame: 9 years). 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 NCT00003892, 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 6 Apr 2020.

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