Cervical CancerPhase 2NCT00138151
Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer
A Phase 2 study testing recombinant interferon alpha-2b, isotretinoin and paclitaxel in people with Cervical Cancer, run by University of Medicine and Dentistry of New Jersey at 6 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- recombinant interferon alpha-2b, isotretinoin and paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2001to Nov 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
DISEASE CHARACTERISTICS:
- Histologically and/or cytologically confirmed cervical cancer, meeting 1 of the following criteria:
- Stage IVB disease
- Recurrent disease
- Persistent disease
- Patients previously treated with chemoradiotherapy as initial therapy must demonstrate disease progression
- Measurable disease by physical exam or radiographic studies
- Not amenable to chemoradiotherapy or surgery
PATIENT CHARACTERISTICS:
Age
- Over 18
Performance status
- ECOG 0-2
Life expectancy
- At least 6 months
Hematopoietic
- WBC ≥ 3,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- SGOT and SGPT ≤ 2 times upper limit of normal
- Bilirubin ≤ 1.5 mg/dL
Renal
- Creatinine ≤ 1.5 mg/dL OR
- Creatinine clearance ≥ 50 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known HIV positivity
- No active infection
- No medical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior interferon
- No other concurrent immunotherapy
Chemotherapy
- See Disease Characteristics
- At least 3 months since prior chemoradiotherapy (6 weeks for patients experiencing disease progression after completion of initial chemoradiotherapy)
- No other prior chemotherapy
Endocrine therapy
- No concurrent hormonal therapy for cancer
Radiotherapy
- See Disease Characteristics
- See Chemotherapy
- Recovered from prior radiotherapy
- No concurrent radiotherapy
Surgery
- Recovered from prior surgery
- No concurrent surgery for cancer
Other
- No prior retinoids
- No other concurrent anticancer therapy
- No other concurrent experimental agents
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, 08690
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, 07962
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Saint Peter's University Hospital
New Brunswick, New Jersey, 08903
UMDNJ University Hospital
Newark, New Jersey, 07103
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase II Trial of Chemosensitization With Paclitaxel, 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving isotretinoin and interferon alpha-2b together with paclitaxel may reduce drug resistance and allow the tumor cells to be killed.
PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alpha-2b together with paclitaxel works in treating patients with stage IV, recurrent, or persistent cervical cancer.
Read the detailed description
OBJECTIVES:
- Determine the response in patients with stage IVB, recurrent, or persistent cervical cancer treated with isotretinoin, interferon alpha-2b, and paclitaxel.
OUTLINE: This is a multicenter study.
Patients receive oral isotretinoin and interferon alpha-2b subcutaneously once daily on days 1-4 and paclitaxel IV over 3 hours on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 27-66 patients will be accrued for this study.
- Conditions
- Cervical Cancer
- Being tested
- recombinant interferon alpha-2b, isotretinoin, paclitaxel
- Keywords
- recurrent cervical cancer, stage IVB cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant interferon alpha-2bBiological
Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
isotretinoinDrug
Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
paclitaxelDrug
Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b | Experimental | * Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
* Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
* Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days Receives: Biological: recombinant interferon alpha-2b; Drug: isotretinoin; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate (Complete and Partial)
All patients who receive at least 3 courses of protocol therapy will be considered evaluable for response of measurable disease.
Measured: 8 years
Secondary outcomes (2)
The Effect of the Regimen on Bcl-2 Family Proteins in Biopsy Specimens and Correlation With Peripheral Blood Mononuclear Cell Bcl-2 Levels.
Measured: 8 years
The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startMar 2001
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Slow accrual and lack of study drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorna Rodriguez, MD, PhD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138151
- Sponsor's protocol ID
- CDR0000433516
- Other IDs
- P30CA072720, CINJ-100101, CINJ-3390, CINJ-NJ1703
- Status last verified
- Sep 2013
- First submitted
- 29 Aug 2005
- Last updated
- 20 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Chemosensitization With Paclitaxel, 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma
- ClinicalTrials.gov ID
- NCT00138151
- Acronym / sponsor ID
- CDR0000433516
- Conditions
- Cervical Cancer
- Keywords
- recurrent cervical cancer, stage IVB cervical cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual and lack of study drug
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2001
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Posted 20 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving isotretinoin and interferon alpha-2b together with paclitaxel may reduce drug resistance and allow the tumor cells to be killed.
PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alpha-2b together with paclitaxel works in treating patients with stage IV, recurrent, or persistent cervical cancer.
Detailed description
OBJECTIVES:
- Determine the response in patients with stage IVB, recurrent, or persistent cervical cancer treated with isotretinoin, interferon alpha-2b, and paclitaxel.
OUTLINE: This is a multicenter study.
Patients receive oral isotretinoin and interferon alpha-2b subcutaneously once daily on days 1-4 and paclitaxel IV over 3 hours on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 27-66 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b | Experimental | Biological: recombinant interferon alpha-2b, Drug: isotretinoin, Drug: paclitaxel* Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle * Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle * Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| recombinant interferon alpha-2bInterferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle | Biological | Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b |
| isotretinoinCis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle | Drug | Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b |
| paclitaxelPaclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days | Drug | Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b |
Primary outcome
Response Rate (Complete and Partial)
Time frame: 8 years
All patients who receive at least 3 courses of protocol therapy will be considered evaluable for response of measurable disease.
2 secondary outcomes
The Effect of the Regimen on Bcl-2 Family Proteins in Biopsy Specimens and Correlation With Peripheral Blood Mononuclear Cell Bcl-2 Levels.
Time frame: 8 years
The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens.
Time frame: 8 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lorna Rodriguez, MD, PhD principal investigator
Rutgers Cancer Institute of New Jersey
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing recombinant interferon alpha-2b, isotretinoin and paclitaxel in people with Cervical Cancer, run by University of Medicine and Dentistry of New Jersey at 6 sites 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?
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 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 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?
Yes. Results are posted in the registry (first posted 20 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response Rate (Complete and Partial) (time frame: 8 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 20 Nov 2013.