Clinical trial · Interventional
Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
A Phase II Evaluation of Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum and Paclitaxel-Resistant Ovarian or Primary Peritoneal Cancer
NCT00023907CI-TRIAL-00010019terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel | Drug | Paclitaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed recurrent or persistent ovarian epithelial or primary peritoneal cancer
* Measurable disease
* At least 1 lesion measured in at least 1 dimension
* At least 20 mm by conventional techniques OR
* At least 10 mm by spiral CT scan
* At least 1 target lesion
* Tumors within a previously irradiated field considered non-target lesions
* Paclitaxel resistant
* Treatment-free interval of less than 6 months duration after treatment with prior paclitaxel OR
* Progression during prior paclitaxel-based therapy
* Platinum resistant or refractory
* Treatment-free interval of less than 6 months duration after treatment with prior platinum OR
* Progression during prior platinum-based therapy
* Ineligible for higher priority GOG protocol (any active GOG phase III protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age:
* Any age
Performance status:
* GOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Other:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection requiring antibiotics
* No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
* No grade 2 or greater neuropathy (sensory and motor)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 3 weeks since prior biologic or immunologic agents for cancer
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy for cancer and recovered
* Received at least 1 but no more than 2 prior platinum-based chemotherapy regimens containing carboplatin, cisplatin, or other organoplatinum compound for primary or recurrent disease
* Initial treatment may include high-dose therapy, consolidation, or extended therapy
* Received at least 1 prior paclitaxel-based chemotherapy regimen
* No prior paclitaxel or docetaxel with a schedule of less than a 3-week interval between doses
* No additional prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
Endocrine therapy:
* At least 1 week since prior hormonal therapy for cancer
* Concurrent hormone replacement therapy allowed
Radiotherapy:
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy for cancer and recovered
* No prior radiotherapy to site(s) of measurable disease
* No prior radiotherapy to more than 25% of marrow-bearing areas
Surgery:
* At least 3 weeks since prior surgery for cancer and recovered
Other:
* At least 3 weeks since other prior therapy for cancer
* No prior anticancer treatment that would preclude study
* No concurrent amifostine or other protective reagentsReferences
Publications (1)
- RESULTGynecologic Oncology Group; Markman M, Blessing J, Rubin SC, Connor J, Hanjani P, Waggoner S. Phase II trial of weekly paclitaxel (80 mg/m2) in platinum and paclitaxel-resistant ovarian and primary peritoneal cancers: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Jun;101(3):436-40. doi: 10.1016/j.ygyno.2005.10.036. Epub 2005 Dec 2. PMID 16325893