Clinical trial · Interventional
Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Multi-Center, Phase Ib/IIa Safety and Preliminary Efficacy Study of Phenoxodiol (Intravenous) as a Chemo-Sensitizing Agent for Cisplatin and Paclitaxel in Epithelial Ovarian Cancer or Primary Peritoneal Cancer, Platinum- and/or Taxane-Refractory or Resistant
- 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, such as cisplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Phenoxodiol may help cisplatin and paclitaxel kill more tumor cells by making tumor cells more sensitive to the drugs. PURPOSE: This randomized phase I/II trial is studying the side effects of phenoxodiol when given together with either cisplatin or paclitaxel and to see how well they work in treating patients with recurrent late-stage ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that has not responded to treatment with drugs such as paclitaxel, docetaxel, cisplatin, or carboplatin.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| phenoxodiol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Phenoxodiol IV 3 mg/kg combined with cisplatin 40 mg/m2 on Day 2 6 week cycles
- interventionNames
- Drug: cisplatin
- Drug: phenoxodiol
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Phenoxodiol IV 3 mg/kg combined with paclitaxel 80 mg/m2 on Day 2 6 week cycles
- interventionNames
- Drug: paclitaxel
- Drug: phenoxodiol
Primary outcomes (2)
- measure
- Safety and tolerability
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer
* Recurrent disease
* Received no more than 4 prior chemotherapy regimens for this malignancy
* Considered refractory or resistant to prior taxane (paclitaxel or docetaxel) and/or platinum (cisplatin or carboplatin) therapy based on 1 of the following criteria:
* Treatment-free interval \< 6 months after platinum or paclitaxel
* Disease progression during platinum- or paclitaxel-based therapy
* Measurable or evaluable disease
* Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* Evaluable disease is defined as doubling of CA 125 blood levels within the past 6 months AND CA 125 level ≥ 2 times upper limit of normal (ULN) within the past week
* No active CNS metastases
* Patients with known CNS metastases must have received prior radiotherapy or CNS-directed chemotherapy AND have ≥ 4 weeks of stable disease
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* Karnofsky 60-100%
Life expectancy
* At least 3 months
Hematopoietic
* Neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* WBC \> 3,000/mm\^3
* Hematocrit ≥ 28% (transfusion or growth factors allowed)
* Hemoglobin \> 8.0 g/dL (transfusion or growth factors allowed)
Hepatic
* Bilirubin ≤ 1.5 times ULN
* SGOT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection requiring antibiotics
* No neuropathy (sensory or motor) \> grade 1
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunotherapy
Chemotherapy
* See Disease Characteristics
* No other concurrent chemotherapy
Endocrine therapy
* No concurrent hormonal therapy for the malignancy
Radiotherapy
* See Disease Characteristics
* No prior whole abdominal radiotherapy
* Concurrent localized radiotherapy allowed for control of local complications not indicative of general disease progression
Surgery
* Not specified
Other
* Recovered from prior antineoplastic therapy
* More than 4 weeks since prior standard therapy for malignant tumor
* More than 6 months since prior investigational anticancer drugs
* No other concurrent investigational drugs
* No concurrent drugs significantly metabolized by the cytochrome P450 enzymes CYP2C8, CYP2C9, CYP2C19, and CYP3A4/B1C
* No concurrent amifostine or other protective agents
* No concurrent grapefruit juiceReferences
Publications (1)
- RESULTKelly MG, Mor G, Husband A, O'Malley DM, Baker L, Azodi M, Schwartz PE, Rutherford TJ. Phase II evaluation of phenoxodiol in combination with cisplatin or paclitaxel in women with platinum/taxane-refractory/resistant epithelial ovarian, fallopian tube, or primary peritoneal cancers. Int J Gynecol Cancer. 2011 May;21(4):633-9. doi: 10.1097/IGC.0b013e3182126f05. PMID 21412168