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Fallopian Tube CancerPhase 3NCT00028743

Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

A Phase 3 study testing carboplatin, cisplatin and paclitaxel in people with Fallopian Tube Cancer and Ovarian Cancer, run by NCIC Clinical Trials Group at 28 sites in Canada.

Completed

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

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different combinations may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
carboplatin, cisplatin and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
819 participants
Where
28 sitesCanada
Study dates
31 Aug 2001to 10 Jan 2013
Phase
Phase 3
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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IIB-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer
  • No borderline ovarian tumors
  • Residual disease allowed
  • Fine needle aspiration showing an adenocarcinoma is allowed instead of open or true-cut biopsy if the following are true:
  • Presence of pelvic mass AND
  • Omental cake or other metastasis larger than 2 cm in the upper abdomen unless proven stage IV disease AND
  • Serum CA 125/carcinoembryonic antigen ratio at least 25 (if less than 25, a barium enema or colonoscopy and gastroscopy or radiological examination of the stomach should be negative for primary tumor within 6 weeks of study) AND
  • Normal mammography within 6 weeks of study

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Granulocyte count at least 2,000/mm^3
  • Platelet count at least 150,000/mm^3

Hepatic:

  • Not specified

Renal:

  • Creatinine no greater than upper limit of normal

Cardiovascular:

  • No clinically relevant atrial or ventricular arrhythmias
  • No myocardial infarction (MI) within the past 6 months (pretreatment ECG as only evidence of MI allowed)
  • No history of second- or third-degree heart blocks unless pacemaker implanted
  • History of first-degree heart block allowed

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No complete bowel obstruction
  • No prior allergic reaction to drugs containing Cremophor EL or compounds chemically related to study drugs
  • No condition that would preclude high-volume saline diuresis
  • No significant neurologic or psychiatric disorder that would preclude study compliance
  • No active uncontrolled infection
  • No neuropathy greater than grade 1
  • No pre-existing hearing loss greater than grade 1
  • No other concurrent serious illness or medical condition that would preclude study participation
  • No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent biological response modifiers or immunotherapy
  • No concurrent prophylactic colony-stimulating factors (CSFs)
  • Concurrent therapeutic CSFs allowed

Chemotherapy:

  • No prior chemotherapy for ovarian cancer
  • No other concurrent cytotoxic agents

Endocrine therapy:

  • No concurrent anticancer hormonal therapy

Radiotherapy:

  • No prior radiotherapy for ovarian cancer

Surgery:

  • No more than 6 weeks since prior planned pre-chemotherapy surgery for ovarian cancer
  • Planned interval debulking allowed
  • Concurrent second-look surgery allowed

Other:

  • No prior non-surgical therapy for ovarian cancer
  • No other concurrent investigational drug therapy
  • No other concurrent anticancer treatment
  • Concurrent enrollment on CAN-NCIC-OV13/EORTC 55971 allowed

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

Canada28 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • PEI Cancer Treatment Centre,Queen Elizabeth Hospital

    Charlottetown, Prince Edward Island, C1A 8T5

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Northeast Cancer Center Health Sciences

    Greater Sudbury, Ontario, P3E 5J1

  • QEII Health Sciences Center

    Halifax, Nova Scotia, B3H 1V7

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • BCCA - Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Cancer Centre of Southeastern Ontario at Kingston

    Kingston, Ontario, K7L 5P9

  • Grand River Regional Cancer Centre

    Kitchener, Ontario, N2G 1G3

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Lions Gate Hospital

    North Vancouver, British Columbia, V7L 2L7

  • Ottawa Health Research Institute - General Division

    Ottawa, Ontario, K1H 8L6

  • CHUQ-Pavillon Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Atlantic Health Sciences Corporation

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Niagara Health System

    St. Catharines, Ontario, L2R 7C6

  • Dr. H. Bliss Murphy Cancer Centre

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

  • BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Thunder Bay Regional Health Science Centre

    Thunder Bay, Ontario, P7B 6V4

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: A Phase III Study of Cisplatin Plus Topotecan Followed by Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Carboplatin as First Line Chemotherapy in Women With Newly Diagnosed Advanced Epithelial Ovarian Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIB, stage III, or stage IV ovarian epithelial cancer , primary peritoneal cancer, or fallopian tube cancer.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of cisplatin and topotecan followed by paclitaxel and carboplatin vs paclitaxel and carboplatin only, in terms of time to disease progression, in patients with newly diagnosed stage IIB-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.
  • Compare the overall survival of patients treated with these regimens.
  • Compare the clinical objective response rates in patients with measurable disease at baseline treated with these regimens.
  • Compare the toxic effects of these regimens in these patients.
  • Compare the CA 125 normalization rates in patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (65 years and under vs over 65 years), and pre-randomization surgery (no debulking vs debulking with macroscopic residual disease less than 1 cm vs debulking with macroscopic residual disease 1 cm or greater vs debulking with no macroscopic residual disease). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive cisplatin IV over 60 minutes on day 1 and topotecan IV over 30 minutes on days 1-5 of courses 1-4 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 5-8.
  • Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 1-8.

In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Planned interval debulking surgery should occur after course 3 or 4.

Quality of life is assessed at baseline; on day 1 of courses 3, 5, and 7; at the end of the last course; and at 3 and 6 months after study treatment completion.

Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this study within 2 years.

Being tested
carboplatin, cisplatin, paclitaxel, topotecan hydrochloride
Keywords
stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

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

  • carboplatinDrug

    Arm 1 = 4 cycles vs Arm 2 = 8 cycles AUC5 (30 mins) day 1 of 21 day cycle

  • cisplatinDrug

    4 cycles 50mg/m2 (60 mins) day 1 of 21 day cycle

  • paclitaxelDrug

    Arm 1 = 4 cycles vs Arm 2 = 8 cycles 175mg/m2 (3 hours) day 1 of 21 day cycle

  • topotecan hydrochlorideDrug

    4 cycles

    .75mg/m2 (30 mins) days 1-5 of 21 day cycle

Study groups in NCT00028743
Study groupRoleWhat they receive
Cisplatin, Topotecan, Paclitaxel plus CarboplatinActive comparatorArm 1
Receives: Drug: carboplatin; Drug: cisplatin; Drug: paclitaxel; Drug: topotecan hydrochloride
Paclitaxel plus CarboplatinActive comparatorArm 2
Receives: Drug: carboplatin; Drug: paclitaxel

What is being measured

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

  1. Progression free survival

    Measured: Mar 2008

Secondary outcomes (5)

  1. Overall Survival

    Measured: Dec 2012

  2. Response Rates

    Measured: March 2008

  3. Toxic Effects

    Measured: March 2008

  4. Quality of Life

    Measured: March 2008

  5. CA125 Normalization Rates

    Measured: March 2008

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study start31 Aug 2001
  3. Primary completion5 Mar 2008
  4. Study completion10 Jan 2013

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
819 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00028743
Sponsor's protocol ID
OV16
Other IDs
CAN-NCIC-OV16, EORTC-55012, GEICO-0101, CDR0000069129
Status last verified
Mar 2020
First submitted
4 Jan 2002
Last updated
2 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hoskins PJ, Vergote I, Stuart G, et al.: A phase III trial of cisplatin plus topotecan followed by paclitaxel plus carboplatin versus standard carboplatin plus paclitaxel as first-line chemotherapy in women with newly diagnosed advanced epithelial ovarian cancer (EOC) (OV.16). A Gynecologic Cancer Intergroup Study of the NCIC CTG, EORTC GCG, and GEICO. [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA5505, 2008.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carboplatin, cisplatin and paclitaxel in people with Fallopian Tube Cancer and Ovarian Cancer, run by NCIC Clinical Trials Group at 28 sites in Canada.

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 2 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 28 sites in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Progression free survival (time frame: Mar 2008). 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 NCT00028743, 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 2 Apr 2020.

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