Recurrent Fallopian Tube CancerPhase 2NCT01200797
SJG-136 in Treating Patients With Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer That Did Not Respond to Previous Treatment With Cisplatin or Carboplatin
A Phase 2 study testing SJG-136 and laboratory biomarker analysis in people with Recurrent Fallopian Tube Cancer and Recurrent Ovarian Epithelial Cancer, run by National Cancer Institute (NCI) at 6 sites in United States.
Trial summary
This phase II trial is studying how well SJG-126 works in treating patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer that did not respond to previous treatment with cisplatin or carboplatin. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer
- What is being tested?
- SJG-136 and laboratory biomarker analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2010to Feb 2013
- 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
Who may be able to join
- Must have persistent or recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma, with histologic confirmation of the original primary tumor.
- Must have had at least one prior platinum-based (cisplatin or carboplatin) chemotherapy regimen for the management of their primary disease. This would include intraperitoneal chemotherapy.
- Must be considered platinum refractory or resistant, defined as patients with progression of disease during platinum-based chemotherapy, patients having persistent disease at the completion of platinum-based chemotherapy, or patients having a disease free interval following prior platinum therapy of less than six months.
- May have had no more than three prior treatment regimens for their epithelial ovarian, primary peritoneal or fallopian tube carcinoma. Consolidation or maintenance therapy initiated within six weeks of the completion of primary therapy will not be counted as an additional regimen.
- Must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
Show all 18Show fewer
- Time interval from last chemotherapy, radiotherapy, or surgery of at least four weeks and the patient must have recovered from any significant adverse effects of prior treatment. Patients must be at least six weeks from having received nitrosoureas or mitomycin C.
- Life expectancy greater than three months.
- Must have adequate bone marrow and organ function:
- Leukocyte count > 3 x 10^9/L
- Absolute neutrophil count (ANC) > 1.5 x 10^9/L
- Platelet count > 100 x 10^9/L
- Total bilirubin Within normal institutional limits
- Aspartate aminotransferase (AST)/alanine transaminase (ALT) < 2.5 x institutional upper limits of normal
- Creatinine < 1.5 mg/dL or calculated creatinine clearance (ClCr) > 60 ml/min by Cockcroft Gault method, as below. ClCr = weight (kg) x (140-age) x 0.85 72 x serum creatinine (mg/dL)
- Participants must have signed an approved informed consent.
- Participants of childbearing potential must have a negative serum pregnancy test prior to study entry and must use an effective form of contraception.
- Must have archival tissue available from their original tumor debulking surgery for assessment of BRCA1 protein expression.
Who cannot join
- Patients with borderline ovarian tumors, ovarian germ cell tumors, ovarian sex-cord stromal tumors, or other non-epithelial ovarian tumors are not eligible.
- Patients receiving any other investigational agents.
- Patients who have received radiation therapy to more than 25% of the bone marrow.
- Patients who have previously received SJG-136 or related compounds.
- Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with the study requirements.
- Prior malignancy (other than cervical carcinoma in situ, ductal carcinoma in situ of the breast, or non-melanoma skin cancer) unless treated with curative intent and without evidence of disease for three years.
- With the exception of alopecia (or other situations in which the organ dysfunction or symptoms are considered clinically insignificant or irrelevant to the study), patients may not have baseline organ dysfunction or symptoms that qualify as grade 2 or higher by the CTEP Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0. Particular attention should be paid to assessment of pre-existing edema, since vascular leak syndrome was the dose limiting toxicity of this agent in the phase I trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Hartford Hospital
Hartford, Connecticut, 06102
Oncology Associates PC
Hartford, Connecticut, 06106
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Virginia Commonwealth University
Richmond, Virginia, 23298
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase II Evaluation of SJG-136 in Women With Cisplatin-Refractory or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma
This phase II trial is studying how well SJG-126 works in treating patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer that did not respond to previous treatment with cisplatin or carboplatin. Drugs used in chemotherapy, such as SJG-136, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate the overall response rate to SJG-136 in patients with persistent or recurrent platinum-refractory epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.
II. To assess the nature and degree of toxicity of this regimen in these patients.
III. To determine other parameters of response, including progression-free survival, overall survival, and time to progression in patients treated with this regimen.
Correlative Endpoints:
- To correlate response rates with the degree of DNA adduct formation in peripheral blood mononuclear cells (PBMCs) and tumor cells as measured by the single-cell gel electrophoresis (Comet) assay and γ-H2AX assay.
II. To assess whether the rate of DNA adduct formation in PBMCs correlates with the rate of DNA adduct formation in tumor cells.
III. To evaluate BRCA1 protein expression in archival tissue specimens from the patient's primary tumor reductive surgery.
IV. To determine the ability of BRCA1 protein in repairing/removing DNA-adducts in PBMCs and tumor tissue.
VI. To evaluate the effect of BRCA1 protein expression on the overall response rate to SJG-136.
OUTLINE: This is a multicenter study.
Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection at baseline and periodically during study for correlative studies. Tumor tissue samples may also be collected.
After completion of study therapy, patients are followed up for 30 days and then annually thereafter.
- Conditions
- Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer
- Being tested
- SJG-136, laboratory biomarker analysis
- Medical subject headings
- Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SJG-136Drug
Given IV
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (SJG-136) | Experimental | Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: SJG-136; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response (OR)
Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD. Confirmation of CR or PR is required to deem either one the best overall response.
Measured: On-treatment date to date of disease progression (assessed up to 12 months)
Number of Patients With Each Worst-grade Toxicity
Count of patients according to the worst-grade toxicity experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening; grade 5, death.
Measured: On-study date to 30 days following final dose of study
Progression-free Survival (PFS)
Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Measured: On-study date to lesser of date of progression or date of (assessed up to 12 months)
Overall Survival (OS)
Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details).
Measured: On-study date to date of death from any cause (assessed up to 12 months)
Time to Progression (TTP)
Estimated probable duration from on-study date to date of disease progression, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Measured: On-study date to date of progression (assessed up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2012
- Study completionFeb 2013
Why it stopped: Slow accrual was the reason for study termination.
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 Recurrent Fallopian Tube CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marta Crispens, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200797
- Sponsor's protocol ID
- NCI-2011-02519
- Other IDs
- NCI-2011-02519, MCC-VICC-GYN-1003, CDR0000682791, VICC GYN 1003, 8489, N01CM00100
- Status last verified
- May 2015
- First submitted
- 10 Sep 2010
- Last updated
- 25 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluation of SJG-136 in Women With Cisplatin-Refractory or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma
- ClinicalTrials.gov ID
- NCT01200797
- Acronym / sponsor ID
- NCI-2011-02519
- Conditions
- Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual was the reason for study termination.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jul 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 14 Sep 2010 (estimated)
- Results
- Posted 25 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying how well SJG-126 works in treating patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer that did not respond to previous treatment with cisplatin or carboplatin. Drugs used in chemotherapy, such as SJG-136, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Detailed description
PRIMARY OBJECTIVES:
- To estimate the overall response rate to SJG-136 in patients with persistent or recurrent platinum-refractory epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.
II. To assess the nature and degree of toxicity of this regimen in these patients.
III. To determine other parameters of response, including progression-free survival, overall survival, and time to progression in patients treated with this regimen.
Correlative Endpoints:
- To correlate response rates with the degree of DNA adduct formation in peripheral blood mononuclear cells (PBMCs) and tumor cells as measured by the single-cell gel electrophoresis (Comet) assay and γ-H2AX assay.
II. To assess whether the rate of DNA adduct formation in PBMCs correlates with the rate of DNA adduct formation in tumor cells.
III. To evaluate BRCA1 protein expression in archival tissue specimens from the patient's primary tumor reductive surgery.
IV. To determine the ability of BRCA1 protein in repairing/removing DNA-adducts in PBMCs and tumor tissue.
VI. To evaluate the effect of BRCA1 protein expression on the overall response rate to SJG-136.
OUTLINE: This is a multicenter study.
Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection at baseline and periodically during study for correlative studies. Tumor tissue samples may also be collected.
After completion of study therapy, patients are followed up for 30 days and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (SJG-136) | Experimental | Drug: SJG-136, Other: laboratory biomarker analysisPatients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Must have persistent or recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma, with histologic confirmation of the original primary tumor.
- Must have had at least one prior platinum-based (cisplatin or carboplatin) chemotherapy regimen for the management of their primary disease. This would include intraperitoneal chemotherapy.
- Must be considered platinum refractory or resistant, defined as patients with progression of disease during platinum-based chemotherapy, patients having persistent disease at the completion of platinum-based chemotherapy, or patients having a disease free interval following prior platinum therapy of less than six months.
- May have had no more than three prior treatment regimens for their epithelial ovarian, primary peritoneal or fallopian tube carcinoma. Consolidation or maintenance therapy initiated within six weeks of the completion of primary therapy will not be counted as an additional regimen.
- Must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Key exclusion criteria (7 listed)
- Patients with borderline ovarian tumors, ovarian germ cell tumors, ovarian sex-cord stromal tumors, or other non-epithelial ovarian tumors are not eligible.
- Patients receiving any other investigational agents.
- Patients who have received radiation therapy to more than 25% of the bone marrow.
- Patients who have previously received SJG-136 or related compounds.
- Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with the study requirements.
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 |
|---|---|---|
| SJG-136Given IV | Drug | Treatment (SJG-136) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (SJG-136) |
Primary outcome
Overall Response (OR)
Time frame: On-treatment date to date of disease progression (assessed up to 12 months)
Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD. Confirmation of CR or PR is required to deem either one the best overall response.
Number of Patients With Each Worst-grade Toxicity
Time frame: On-study date to 30 days following final dose of study
Count of patients according to the worst-grade toxicity experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening; grade 5, death.
Progression-free Survival (PFS)
Time frame: On-study date to lesser of date of progression or date of (assessed up to 12 months)
Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Overall Survival (OS)
Time frame: On-study date to date of death from any cause (assessed up to 12 months)
Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details).
Time to Progression (TTP)
Time frame: On-study date to date of progression (assessed up to 12 months)
Estimated probable duration from on-study date to date of disease progression, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
- 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.
Marta Crispens principal investigator
H. Lee Moffitt Cancer Center and Research Institute
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 SJG-136 and laboratory biomarker analysis in people with Recurrent Fallopian Tube Cancer and Recurrent Ovarian Epithelial Cancer, run by National Cancer Institute (NCI) 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?
The sponsor lists 18 inclusion and 7 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 25 May 2015. 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 25 May 2015). 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?
Overall Response (OR) (time frame: On-treatment date to date of disease progression (assessed up to 12 months)). The study lists 5 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 25 May 2015.