Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
CompletedPhase 2Results postedLast updated 20 October 2021
What this trial tests
Phase 2 trial testing Elesclomol Sodium in Fallopian Tube Clear Cell Adenocarcinoma in 58 participants. Completed in 31 August 2016.
18 and older, female only, with Fallopian Tube Clear Cell Adenocarcinoma or Fallopian Tube Endometrioid Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Participants With Objective ResponsePrimary· Up to 5 years
Proportion of Participants with Object Response (per response evaluation criteria in solid tumors criteria (RECIST V1.1) for target lesions as assessed by MRI: Complete Response (CR), disappearance of all target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Group
Value
95% CI
Treatment (Paclitaxel, Elesclomol Sodium)
0.196
0.114 – 0.304
Duration of Objective ResponsePrimary· Up to 5 years
Duration of objective response (months)
Group
Value
95% CI
Treatment (Paclitaxel, Elesclomol Sodium)
9.2
5.5 – 14.9
Number of Participants Who Experienced at Least One Adverse EventPrimary· Up to 5 years
The frequency of patients who experienced at least one adverse effect (with a grade of 1 or higher). Adverse effects are defined as any unfavorable and unintended sign, symptom, or disease that occurs in a patient administered a medical treatment, whether the event is considered related or unrelated to the medical treatment.
Group
Value
95% CI
Treatment (Paclitaxel, Elesclomol Sodium)
56
The Number of Participants Who Experienced at Least One Grade 3 Adverse EventPrimary· Up to 5 years
The number of participants who experienced at least one grade three (or higher) adverse effect. The severity of observed adverse effects is graded using the NCI CTCAE version 4.0.
Group
Value
95% CI
Treatment (Paclitaxel, Elesclomol Sodium)
26
Progression-free Survival (Median)Secondary· From start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years
Progression-free survival (median, in months) will be analyzed by Kaplan-Meier analysis (progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (also a 5 mm absolute increase is also required), or a measurable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
Treatment (Paclitaxel, Elesclomol Sodium)
3.6
2.03 – 5.65
Overall Survival (Median)Secondary· From start of treatment to time of death or the date of last contact, assessed up to 5 years
Overall survival (median, in months) will be analyzed by Kaplan-Meier analysis.
Group
Value
95% CI
Treatment (Paclitaxel, Elesclomol Sodium)
13.3
10.38 – 19.45
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Paclitaxel, Elesclomol Sodium)
Serious: 18/56 (32%)
Deaths: 43/56
Serious adverse events (15 terms)
Reaction
System
Treatment (Paclitaxel, Ele…
Hyperglycemia
Metabolism and nutrition disorders
—
Small Intestinal Obstruction
Gastrointestinal disorders
—
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
—
Atrial Fibrillation
Cardiac disorders
—
Pericardial Effusion
Cardiac disorders
—
Colonic Hemorrhage
Gastrointestinal disorders
—
Bloating
Gastrointestinal disorders
—
Ileus
Gastrointestinal disorders
—
Nausea
Gastrointestinal disorders
—
Skin Infection
Infections and infestations
—
Lung Infection
Infections and infestations
—
Dehydration
Metabolism and nutrition disorders
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
Surgical And Medical Procedures - Other
Surgical and medical procedures
—
Other adverse events (151 terms — click to expand)
This phase II trial studies how well elesclomol sodium and paclitaxel work in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that has returned after a period of improvement (recurrent) or is persistent. Drugs used in chemotherapy, such as elesclomol sodium and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Elesclomol sodium may also help paclitaxel work better by making tumor cells more sensitive to the drug.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Other recruiting trials for Fallopian Tube Clear Cell Adenocarcinoma
Currently open trials in the same condition.
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NCT04919629 — APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurr
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NCT04575935 — Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal
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NCT04092270 — A Study Combining the Peposertib (M3814) Pill With Standard Chemotherapy in Patients With Ovarian Cancer With an Expansi
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NCT02502266 — Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Pl
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Other GOG Foundation trials
Trials by the same sponsor.
NCT05154487 — A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer
· Phase 2
· active not recruiting
NCT05659381 — Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer
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· recruiting
NCT01649089 — Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer
· NA
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NCT01535053 — Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GOG Foundation
Last refreshed: 20 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00888615.