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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

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ClinicalTrials.gov Identifier: NCT01200797
Recruitment Status : Terminated (Slow accrual was the reason for study termination.)
First Posted : September 14, 2010
Results First Posted : May 25, 2015
Last Update Posted : May 25, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment Phase
Recurrent Fallopian Tube Cancer Recurrent Ovarian Epithelial Cancer Recurrent Primary Peritoneal Cavity Cancer Drug: SJG-136 Other: laboratory biomarker analysis Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

I. 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of SJG-136 in Women With Cisplatin-Refractory or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma
Study Start Date : July 2010
Primary Completion Date : October 2012
Study Completion Date : February 2013


Arms and Interventions

Arm Intervention/treatment
Experimental: Treatment (SJG-136)
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.
Drug: SJG-136
Given IV
Other: laboratory biomarker analysis
Correlative studies


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200797


Locations
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Oncology Associates PC
Hartford, Connecticut, United States, 06106
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Marta Crispens H. Lee Moffitt Cancer Center and Research Institute
More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01200797     History of Changes
Obsolete Identifiers: NCT01199796
Other Study ID Numbers: NCI-2011-02519
NCI-2011-02519 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MCC-VICC-GYN-1003
CDR0000682791
VICC GYN 1003 ( Other Identifier: H. Lee Moffitt Cancer Center and Research Institute )
8489 ( Other Identifier: CTEP )
N01CM00100 ( U.S. NIH Grant/Contract )
First Posted: September 14, 2010    Key Record Dates
Results First Posted: May 25, 2015
Last Update Posted: May 25, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Fallopian Tube Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Cisplatin
Antineoplastic Agents