Phase 2
Completed N=30
Dalantercept in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Recurrent Fallopian Tube Carcinoma · Ovarian Cancer · Recurrent Primary Peritoneal Carcinoma
Source: ClinicalTrials.gov NCT01720173 ↗
Enrolled (actual)
30
Serious AEs
26.7%
Results posted
Dec 2017
Primary outcomePrimary: Progression-free for at Least 6 Months Without Non-protocol Therapy From Study Entry — 20 percentage of participants
Summary
This phase II trial studies the side effects and how well dalantercept works in treating patients with ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer that has returned. Dalantercept may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Dalantercept may also stop the growth of tumor cells by blocking blood flow to the tumor.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free for at Least 6 Months Without Non-protocol Therapy From Study Entry |
20 | — |
| PRIMARY Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 |
1; 1; 3; 2; 2; 3 | — |
| PRIMARY Objective Tumor Response |
— | — |
| SECONDARY Overall Survival |
19.8 | — |
| SECONDARY Progression-free Survival |
1.7 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report
- All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
- Patient must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
- Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III protocol or Rare Tumor protocol for the same patient population
- Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2; patients who have received two prior regimens must have a GOG performance status of 0 or 1
- Recovery from effects of recent surgery, radiotherapy, or chemotherapy:
- Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted
- Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration; therapy with nitrosoureas or mitomycin must be discontinued at least six weeks prior to registration
- Any prior radiation therapy must be discontinued at least four weeks prior to registration
- At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy); there is no delay in treatment for minor procedures (e.g., central venous access catheter placement)
- Prior therapy:
- Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents (e.g., bevacizumab) or extended therapy administered after surgical or non-surgical assessment
- Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease
- Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease), must have a platinum-free interval of less than 12 months, or have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy
- Patients are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy as part of their primary treatment regimen
- Patients must have NOT received any biologic/targeted (non-cytotoxic) therapy targeting the VEGF pathway for management of recurrent or persistent disease
- For the purposes of this study, poly (ADP-ribose) polymerase (PARP) inhibitors will be considered ?cytotoxic?; patients are allowed to receive, but are not required to receive, PARP inhibitors for management of primary or recurrent/persistent disease (either alone or in combination with cytotoxic chemotherapy); PARP inhibitors will NOT count as a prior regi
Data sourced from ClinicalTrials.gov (NCT01720173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.