Fallopian Tube CancerPhase 1/2NCT00085384
PEG-Interferon Alfa-2b in Treating Patients With Platinum-Resistant Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
A Phase 1/2 study testing PEG-interferon alfa-2b in people with Fallopian Tube Cancer and Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of cancer cells. PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of PEG-interferon alfa-2b and to see how well it works in treating patients with ovarian epithelial, peritoneal, or fallopian tube cancer that is… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
- What is being tested?
- PEG-interferon alfa-2b
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Apr 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women with platinum-resistant epithelial ovarian, fallopian tube or peritoneal cancer whose tumor test positive for IL-8 (>31.0 pg/ml), bFGF >7.0 pg/ml), or VEGF (>700 pg/ml). Resistance is defined as:
- Progression of disease during platinum chemotherapy, or
- Progression of disease within 6 months of completing platinum chemotherapy
- Failure to achieve a complete response, with persistent macroscopic disease, after 6 cycles of chemotherapy, if the last two cycles had no measurable change in disease status
- Patients with a known hypersensitivity to platinum compounds who have failed a desensitization regimen, or who are not good candidates for desensitization are eligible.
- Patients are limited to 4 prior chemotherapy regimens (all platinum and taxane regimens to be counted as one).
Show all 14Show fewer
- Patients must have measurable disease.
- Women of any racial and ethnic group.
- Zubrod performance status < 2.
- Expected survival of > 12 weeks.
- Patients must have adequate hepatic, renal, and bone marrow function, defined as serum creatinine < 2 mg/dl (estimated creatinine clearance 50 ml/min); total bilirubin < 2.0 X the upper limit of normal (ULN); alanine aminotransferase (ALT) < 2X ULN; fasting triglycerides < 800 mg/dL; white blood count (WBC) > 3,000/mm3 ; absolute neutrophil count (ANC) > 1,500/mm3; platelets > 100,000/mm3, hemoglobin > 9 g/dl.
- At least three weeks must have elapsed from completion of chemotherapy.
- Patient agrees not to use complementary alternative medications (e.g., shark cartilage).
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the hospital. The only approved consent is appended to this protocol.
Who cannot join
- Patients with borderline, low grade or low malignant potential tumors are not eligible.
- Patients who are pregnant or lactating.
- Concurrent chemotherapy, radiation therapy or surgery.
- Concurrent, uncontrolled, medical or psychiatric disorders.
- Patients with a known hypersensitivity to interferon.
- Patients with severe cardiovascular disease (i.e. arrhythmias requiring chronic treatment or congestive heart failure) (NYHA classification III or IV).
Show all 9Show fewer
- Patients who have had interferon within the last 6 months.
- Patients with overt psychosis or mental disability or otherwise incompetent to give informed consent.
- Patients with a known autoimmune disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Study to Evaluate the Optimum Dose of Pegylated-Interferon (PEG INTRON) in Patients With Platinum Resistant Ovarian, Peritoneal or Fallopian Tube Cancer
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of cancer cells.
PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of PEG-interferon alfa-2b and to see how well it works in treating patients with ovarian epithelial, peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.
Read the detailed description
OBJECTIVES:
- Determine the optimum biologic dose of PEG-interferon alfa-2b in patients with platinum-resistant ovarian epithelial, peritoneal, or fallopian tube cancer.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 different treatment arms.
- Arm I: Patients receive PEG-interferon alfa-2b (PEG IFN-α) subcutaneously (SC) on days 1, 8, 15, and 22.
- Arm II: Patients receive PEG IFN-α SC (at a higher dose than in arm I) on days 1, 8, 15, and 22.
- Arm III: Patients receive PEG IFN-α SC (at a higher dose than in arm II) on days 1, 8, 15, and 22.
In all arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for at least 28 days after study treatment.
PROJECTED ACCRUAL: A maximum of 75 patients will be accrued for this study within 19 months.
- Being tested
- PEG-interferon alfa-2b
- Keywords
- recurrent ovarian epithelial cancer, peritoneal cavity cancer, fallopian tube 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.
PEG-interferon alfa-2bBiological
Also called PEG-Intron
Starting dose 1.0 mg/kg/week given subcutaneously
PEG-interferon alfa-2bDrug
Also called PEG-Intron
Biological/Vaccine: PEG-interferon alfa-2b
Dose 1.25 mg/kg/week given subcutaneously
PEG-interferon alfa-2bBiological
Also called PEG-Intron
Biological/Vaccine: PEG-interferon alfa-2b
Dose 1.5 mg/kg/week given subcutaneously
EG-Intron
| Study group | Role | What they receive |
|---|---|---|
| PEG-interferon alfa-2b | Experimental | Patients receive PEG-interferon alfa-2b (PEG IFN-α) subcutaneously (SC) on days 1, 8, 15, and 22. Receives: Biological: PEG-interferon alfa-2b |
| Arm II | Experimental | Patients receive PEG IFN-α SC (at a higher dose than in arm I) on days 1, 8, 15, and 22. Receives: Drug: PEG-interferon alfa-2b |
| Arm III | Experimental | Patients receive PEG IFN-α SC (at a higher dose than in arm II) on days 1, 8, 15, and 22. Receives: Biological: PEG-interferon alfa-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Biologic Dose at 8 weeks
Optimum biologic dose of PEG Intron in patients with platinum-resistant ovarian, fallopian tube or peritoneal cancer whose tumors test positive for IL-8, BFGF, or VEGF.
Measured: 8 weeks
Tumor Response
Each patient tumor response scored as either complete/partial response (CR/PR), stable disease (SD), or failure (F) at 8 weeks after initial treatment.
Measured: Every 2 -3 cycles (8 - 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
- Study startJul 2002
- Primary completionNov 2005
- Study completionApr 2007
Why it stopped: Terminated due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Judith K. Wolf, MD, Study chair, M.D. Anderson Cancer CenterPedro T. Ramirez, MD, Study chair, M.D. Anderson Cancer CenterDiane C. Bodurka, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00085384
- Sponsor's protocol ID
- ID02-115
- Other IDs
- P50CA083639, P30CA016672, MDA-ID-02115, CDR0000368964
- Status last verified
- Aug 2012
- First submitted
- 10 Jun 2004
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate the Optimum Dose of Pegylated-Interferon (PEG INTRON) in Patients With Platinum Resistant Ovarian, Peritoneal or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT00085384
- Acronym / sponsor ID
- ID02-115
- Keywords
- recurrent ovarian epithelial cancer, peritoneal cavity cancer, fallopian tube cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow accrual.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2002
- Primary completion
- Nov 2005 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 11 Jun 2004 (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.
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of cancer cells.
PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of PEG-interferon alfa-2b and to see how well it works in treating patients with ovarian epithelial, peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.
Detailed description
OBJECTIVES:
- Determine the optimum biologic dose of PEG-interferon alfa-2b in patients with platinum-resistant ovarian epithelial, peritoneal, or fallopian tube cancer.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 different treatment arms.
- Arm I: Patients receive PEG-interferon alfa-2b (PEG IFN-α) subcutaneously (SC) on days 1, 8, 15, and 22.
- Arm II: Patients receive PEG IFN-α SC (at a higher dose than in arm I) on days 1, 8, 15, and 22.
- Arm III: Patients receive PEG IFN-α SC (at a higher dose than in arm II) on days 1, 8, 15, and 22.
In all arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for at least 28 days after study treatment.
PROJECTED ACCRUAL: A maximum of 75 patients will be accrued for this study within 19 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEG-interferon alfa-2b | Experimental | Biological: PEG-interferon alfa-2bPatients receive PEG-interferon alfa-2b (PEG IFN-α) subcutaneously (SC) on days 1, 8, 15, and 22. |
| Arm II | Experimental | Drug: PEG-interferon alfa-2bPatients receive PEG IFN-α SC (at a higher dose than in arm I) on days 1, 8, 15, and 22. |
| Arm III | Experimental | Biological: PEG-interferon alfa-2bPatients receive PEG IFN-α SC (at a higher dose than in arm II) on days 1, 8, 15, and 22. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Women with platinum-resistant epithelial ovarian, fallopian tube or peritoneal cancer whose tumor test positive for IL-8 (>31.0 pg/ml), bFGF >7.0 pg/ml), or VEGF (>700 pg/ml). Resistance is defined as:
- Patients with a known hypersensitivity to platinum compounds who have failed a desensitization regimen, or who are not good candidates for desensitization are eligible.
- Patients are limited to 4 prior chemotherapy regimens (all platinum and taxane regimens to be counted as one).
- Patients must have measurable disease.
- Women of any racial and ethnic group.
Key exclusion criteria (9 listed)
- Patients with borderline, low grade or low malignant potential tumors are not eligible.
- Patients who are pregnant or lactating.
- Concurrent chemotherapy, radiation therapy or surgery.
- Concurrent, uncontrolled, medical or psychiatric disorders.
- Patients with a known hypersensitivity to interferon.
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 |
|---|---|---|
| PEG-interferon alfa-2bAlso: PEG-IntronStarting dose 1.0 mg/kg/week given subcutaneously | Biological | PEG-interferon alfa-2b |
| PEG-interferon alfa-2bAlso: PEG-IntronBiological/Vaccine: PEG-interferon alfa-2b Dose 1.25 mg/kg/week given subcutaneously | Drug | Arm II |
| PEG-interferon alfa-2bAlso: PEG-IntronBiological/Vaccine: PEG-interferon alfa-2b Dose 1.5 mg/kg/week given subcutaneously EG-Intron | Biological | Arm III |
Primary outcome
Optimal Biologic Dose at 8 weeks
Time frame: 8 weeks
Optimum biologic dose of PEG Intron in patients with platinum-resistant ovarian, fallopian tube or peritoneal cancer whose tumors test positive for IL-8, BFGF, or VEGF.
Tumor Response
Time frame: Every 2 -3 cycles (8 - 12 weeks)
Each patient tumor response scored as either complete/partial response (CR/PR), stable disease (SD), or failure (F) at 8 weeks after initial treatment.
Results and safety
The study was stopped early (reason given: Terminated due to slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
- UT MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Fallopian Tube Cancer
RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Fallopian Tube Carcinoma, Ovarian Carcinoma
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
Recruiting
MIRRORS-FROZEN - Comparing Open Vs Robotic Surgery in the Management of Women With Complex Pelvic Adnexal Masses ≤ 8cm.
Ovarian Cancer, Ovarian Mass
RecruitingPhase 3
A Clinical Trial of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab in Participants With Ovarian Cancer Who Have Progressed During Treatment With PARP-inhibitors Treatment on First Line Maintenance (MK-5909-008/ENGOT-ov107/GOG-3142 / REJOICE-Ovarian05)
Ovarian Cancer, Peritoneal Cancer
RecruitingPhase 1/2
A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003).
Ovarian Cancer Recurrent
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.
Judith K. Wolf, MD study chair
M.D. Anderson Cancer Center
Pedro T. Ramirez, MD study chair
M.D. Anderson Cancer Center
Diane C. Bodurka, MD study chair
M.D. Anderson Cancer 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 PEG-interferon alfa-2b in people with Fallopian Tube Cancer and Ovarian Cancer, run by M.D. Anderson Cancer Center 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 14 inclusion and 9 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 2 Aug 2012. 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 was stopped early (reason given: Terminated due to slow accrual.). 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?
Optimal Biologic Dose at 8 weeks (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 2 Aug 2012.