Phase 2
N=27
Veliparib, Topotecan Hydrochloride, and Filgrastim or Pegfilgrastim in Treating Patients With Persistent or Recurrent Cervical Cancer
Cervical Adenocarcinoma · Cervical Adenosquamous Carcinoma · Cervical Small Cell Carcinoma · Cervical Squamous Cell Carcinoma · Recurrent Cervical Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01266447 ↗Enrolled (actual)
27
Serious AEs
59.3%
Results posted
Feb 2017
Primary outcome: Primary: Tumor Response — 7.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Filgrastim (Biological); Laboratory Biomarker Analysis (Other); Pegfilgrastim (Biological); Topotecan Hydrochloride (Drug); Veliparib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Response |
7.4 | — |
| PRIMARY Number of Patients With Dose-limiting Toxicities (in Safety lead-in) |
1 | — |
| PRIMARY Adverse Events (Grade 3 or Higher) During Treatment Period |
6; 12; 5; 16; 4; 1 | — |
| SECONDARY Progression-free Survival |
2.0 | — |
| SECONDARY Overall Survival |
8.2 | — |
| SECONDARY Duration of Objective Response |
5.3 | — |
Summary
This phase II clinical trial is studying the how well veliparib, topotecan hydrochloride, and filgrastim or pegfilgrastim work in treating patients with persistent or recurrent cervical cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by blocking them from dividing. Giving veliparib with chemotherapy may kill more tumor cells. Filgrastim or pegfilgrastim may cause the body to make more blood cells and help it recover from the side effects of chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Patients must have persistent or recurrent squamous cell carcinoma, adenosquamous carcinoma, adenocarcinoma or non-squamous cell carcinoma of the cervix with documented disease progression; histological documentation of the original primary tumor is required via the pathology report
- All patients must have measurable disease as defined by 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 must have a GOG performance status of 0, 1, or 2
- Recovery from effects of recent surgery, radiotherapy, or chemotherapy
- Patients should be free of active infection requiring antibiotics
- 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 chemotherapy, biologic/targeted (non-cytotoxic) therapy and immunologic agents must be discontinued at least three weeks prior to registration; all side effects must have resolved to = 3 months after treatment and off steroid treatment prior to study enrollment
Data sourced from ClinicalTrials.gov (NCT01266447). 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.