Phase 2
N=51
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Fallopian Tube Carcinoma · Primary Peritoneal Carcinoma · Recurrent Ovarian Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00499252 ↗Enrolled (actual)
51
Serious AEs
23.4%
Results posted
Dec 2013
Primary outcome: Primary: Tumor Response — 23.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Paclitaxel Albumin-Stabilized Nanoparticle Formulation (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Gynecologic Oncology Group
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Response |
23.4 | — |
| PRIMARY Frequency and Severity of Observed Adverse Effects |
20; 15; 11; 1; 43; 4 | — |
| SECONDARY Progression-free Survival |
4.5 | — |
| SECONDARY Overall Survival |
17.4 | — |
Summary
This phase II trial is studying the side effects and how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed diagnosis of 1 of the following:
- Ovarian epithelial cancer
- Fallopian tube cancer
- Primary peritoneal carcinoma
- Recurrent or persistent disease
- Must have received 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
- Initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, or extended therapy administered after a surgical or nonsurgical assessment
- Patients who have not received prior paclitaxel-based chemotherapy must receive a second regimen that includes paclitaxel or docetaxel
- Platinum-resistant or refractory disease, defined by 1 of the following:
- Treatment-free interval of grade 1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PT INR ≤ 1.5 or in-range INR 2-3 (if patient is on a stable dose of therapeutic warfarin)
- PTT 3 years ago and patient remains free of recurrent or metastatic disease
- More than 5 years since prior radiotherapy to any other portion of the abdominal cavity or pelvis, unless for treatment of ovarian, primary peritoneal, or fallopian tube cancer
- Prior radiotherapy for localized breast cancer, cancer of the head and neck, or skin cancer allowed provided it was completed > 3 years ago and patient remains free of recurrent or metastatic disease
- No prior radiotherapy to > 25% of marrow-bearing areas
Data sourced from ClinicalTrials.gov (NCT00499252). 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.