Ovarian CarcinomaPhase 3NCT00047632
Safety and Efficacy of Interferon Gamma-1b Plus Chemotherapy for Ovarian and Peritoneal Cancer
A Phase 3 study testing Interferon gamma-1b in people with Ovarian Carcinoma and Peritoneal Carcinoma, run by InterMune at 1 site in United States.
Trial summary
The purposes of this study are to determine: 1) if treatment with interferon gamma-1b plus standard chemotherapy (carboplatin and paclitaxel) can increase the overall survival of patients with advanced ovarian or primary peritoneal carcinoma compared with chemotherapy alone; 2) how effective interferon gamma-1b plus… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Carcinoma, Peritoneal Carcinoma
- What is being tested?
- Interferon gamma-1b
- How many people
- 847 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to Feb 2006
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed epithelial ovarian or primary peritoneal carcinoma, FIGO Stage III or IV disease. Patients with either optimal (<= 1 cm residual disease) or suboptimal residual disease following initial surgery are eligible. Unstained slides of the primary tumor, a primary tumor block, or cytological preparation must be available for review.
- Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.
- <= 12 weeks after initial surgery with adequate recovery from surgery.
- Candidate for first-line chemotherapy
- Adequate bone marrow function (ANC >= 1,500/mL; platelets >= 100,000/mL; hemoglobin >= 10 gm/dL)
- Adequate hepatic function (AST, ALT, and alkaline phosphatase <= 2.5 x upper limit of normal; bilirubin <= 1.5 x upper limit of normal).
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- Adequate renal function (creatinine <= 1.5 x upper limit of normal).
- Adequate neurologic function (sensory and motor neuropathy <= NCI CTC Grade 1).
- Negative urine pregnancy test in women of child-bearing potential (within 14 days of the initiation of the first chemotherapy cycle).
- Zubrod / ECOG / GOG performance score 0-2.
- Able to give informed consent.
Who cannot join
- Epithelial ovarian tumors of low malignant potential (borderline carcinomas). If diagnosis is based on cytology alone [(e.g., fine needle aspiration (FNA)], slides must be available, and confounding carcinomas such as non-ovarian mucinous, colorectal, Fallopian tube, and other adenocarcinomas of non-ovarian origin must be ruled out.
- Prior therapy for ovarian or primary peritoneal carcinoma other than primary surgical debulking.
- Patients for whom therapy for ovarian or primary peritoneal carcinoma in addition to protocol therapy is planned.
- Prior biological response modifier (BRM) for any reason within the previous 5 years.
- Prior malignancy within the previous 5 years other than basal cell or squamous cell carcinomas or in situ carcinoma of the cervix. Patients who have had a malignancy > 5 years previously may be eligible for this trial if they have not received any anti-neoplastic treatment within the previous 5 years an dif they have been without any evidence of disease for the previous 5 years.
- Uncontrolled infection.
- Pregnant or nursing women are excluded. Women of child-bearing potential must agree to use a chemical or barrier contraceptive during the dosing portion of the study.
- Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any of the study's endpoints.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interferon Gamma-1b in Combination With Chemotherapy (Carboplatin/Paclitaxel) for First Line Therapy of Advanced Ovarian or Primary Peritoneal Carcinoma.
The purposes of this study are to determine: 1) if treatment with interferon gamma-1b plus standard chemotherapy (carboplatin and paclitaxel) can increase the overall survival of patients with advanced ovarian or primary peritoneal carcinoma compared with chemotherapy alone; 2) how effective interferon gamma-1b plus standard chemotherapy is in preventing the progression or return of cancer; 3) the effects on quality of life; and 4) the safety of interferon gamma-1b combined with standard chemotherapy compared to chemotherapy alone.
Read the detailed description
Approximately 800 patients will receive either chemotherapy alone or chemotherapy plus Interferon gamma-1b. Chemotherapy will be paclitaxel (175 mg/m2 over 3 hours) followed by carboplatin (AUC 6) every 3 weeks. Only those patients in the treatment arm will receive interferon doses. Interferon gamma-1b 100 mg will be administered subcutaneously 3 times per week (every other day; no more than 3 doses in a 7-day period) continuously while patients are treated with carboplatin / paclitaxel (including for the 3 weeks following the last dose of chemotherapy). A total of 6 cycles of chemotherapy will be given unless disease progression or liming toxicity occurs or patients refuse further treatment. Each patient will receive a total of 54 doses over a period of 18 weeks. Each patient's participation will be from 3-8 years in duration.
- Conditions
- Ovarian Carcinoma, Peritoneal Carcinoma
- Being tested
- Interferon gamma-1b
- Keywords
- ovarian, carcinoma, peritoneal, cancer, ovary, interferon gamma
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon gamma-1bDrug
100 mcg, SQ, 3x per week
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival time assessed at end of study
Measured: 4 years
Secondary outcomes (3)
Progression-free survival time assessed at interim analysis
Measured: 4 years
Treatment failure-free survival time assessed at end of study
Measured: 4 years
Quality of life assessed through 24 months after end of treatment
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2002 (estimated)
- Study startOct 2001
- Study completionFeb 2006
Why it stopped: futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 847 participants (actual)
Sponsor and investigators
- Lead sponsor
- InterMune
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- InterMune, Inc. 888-486-6411, Medical Information
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047632
- Sponsor's protocol ID
- GIOV-001
- Status last verified
- Oct 2007
- First submitted
- 9 Oct 2002
- Last updated
- 1 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interferon Gamma-1b in Combination With Chemotherapy (Carboplatin/Paclitaxel) for First Line Therapy of Advanced Ovarian or Primary Peritoneal Carcinoma.
- ClinicalTrials.gov ID
- NCT00047632
- Acronym / sponsor ID
- GIOV-001
- Conditions
- Ovarian Carcinoma, Peritoneal Carcinoma
- Keywords
- ovarian, carcinoma, peritoneal, cancer, ovary, interferon gamma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: futility
- Enrolment
- 847 participants (actual)
- Lead sponsor
- InterMuneIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Study completion
- Feb 2006 (actual)
- First posted
- 11 Oct 2002 (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 purposes of this study are to determine: 1) if treatment with interferon gamma-1b plus standard chemotherapy (carboplatin and paclitaxel) can increase the overall survival of patients with advanced ovarian or primary peritoneal carcinoma compared with chemotherapy alone; 2) how effective interferon gamma-1b plus standard chemotherapy is in preventing the progression or return of cancer; 3) the effects on quality of life; and 4) the safety of interferon gamma-1b combined with standard chemotherapy compared to chemotherapy alone.
Detailed description
Approximately 800 patients will receive either chemotherapy alone or chemotherapy plus Interferon gamma-1b. Chemotherapy will be paclitaxel (175 mg/m2 over 3 hours) followed by carboplatin (AUC 6) every 3 weeks. Only those patients in the treatment arm will receive interferon doses. Interferon gamma-1b 100 mg will be administered subcutaneously 3 times per week (every other day; no more than 3 doses in a 7-day period) continuously while patients are treated with carboplatin / paclitaxel (including for the 3 weeks following the last dose of chemotherapy). A total of 6 cycles of chemotherapy will be given unless disease progression or liming toxicity occurs or patients refuse further treatment. Each patient will receive a total of 54 doses over a period of 18 weeks. Each patient's participation will be from 3-8 years in duration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed epithelial ovarian or primary peritoneal carcinoma, FIGO Stage III or IV disease. Patients with either optimal (<= 1 cm residual disease) or suboptimal residual disease following initial surgery are eligible. Unstained slides of the primary tumor, a primary tumor block, or cytological preparation must be available for review.
- Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.
- <= 12 weeks after initial surgery with adequate recovery from surgery.
- Candidate for first-line chemotherapy
- Adequate bone marrow function (ANC >= 1,500/mL; platelets >= 100,000/mL; hemoglobin >= 10 gm/dL)
Key exclusion criteria (8 listed)
- Epithelial ovarian tumors of low malignant potential (borderline carcinomas). If diagnosis is based on cytology alone [(e.g., fine needle aspiration (FNA)], slides must be available, and confounding carcinomas such as non-ovarian mucinous, colorectal, Fallopian tube, and other adenocarcinomas of non-ovarian origin must be ruled out.
- Prior therapy for ovarian or primary peritoneal carcinoma other than primary surgical debulking.
- Patients for whom therapy for ovarian or primary peritoneal carcinoma in addition to protocol therapy is planned.
- Prior biological response modifier (BRM) for any reason within the previous 5 years.
- Prior malignancy within the previous 5 years other than basal cell or squamous cell carcinomas or in situ carcinoma of the cervix. Patients who have had a malignancy > 5 years previously may be eligible for this trial if they have not received any anti-neoplastic treatment within the previous 5 years an dif they have been without any evidence of disease for the previous 5 years.
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 |
|---|---|---|
| Interferon gamma-1b100 mcg, SQ, 3x per week | Drug | – |
Primary outcome
Overall survival time assessed at end of study
Time frame: 4 years
3 secondary outcomes
Progression-free survival time assessed at interim analysis
Time frame: 4 years
Treatment failure-free survival time assessed at end of study
Time frame: 4 years
Quality of life assessed through 24 months after end of treatment
Time frame: 4 years
Results and safety
The study was stopped early (reason given: futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2007.
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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.
InterMune, Inc. 888-486-6411
Medical Information
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interferon gamma-1b in people with Ovarian Carcinoma and Peritoneal Carcinoma, run by InterMune 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 11 inclusion and 8 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: stopped early, as of the sponsor's last update on 1 Nov 2007. 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 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 was stopped early (reason given: futility). Results are not available in the source record.
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?
Overall survival time assessed at end of study (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2007.