Clinical trial · Interventional
Intraperitoneal Paclitaxel, Doxorubicin Hydrochloride, and Cisplatin in Treating Patients With Stage III-IV Endometrial Cancer
A Phase I Study of IV Doxorubicin Plus Intraperitoneal (IP) Paclitaxel and IV or IP Cisplatin in Endometrial Cancer Patients at High Risk for Peritoneal Failure
NCT00575952CI-TRIAL-00029234completedPhase 1ClinicalTrials.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)
This phase I trial studies the side effects and best dose of intraperitoneal paclitaxel when given together with doxorubicin hydrochloride and cisplatin in treating patients with stage III-IV endometrial cancer. Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Adenosquamous Carcinoma | Endometrial Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Clear Cell Adenocarcinoma | Endometrial Clear Cell Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Mixed Adenocarcinoma | — | UNRESOLVED | — |
| Endometrial Serous Adenocarcinoma | Endometrial Serous Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Squamous Cell Carcinoma | Endometrial Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Undifferentiated Carcinoma | Endometrial Undifferentiated Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Uterine Corpus Carcinoma | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Doxorubicin Hydrochloride | Drug | Doxorubicin | ALIAS |
| Filgrastim | Biological | Filgrastim | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (doxorubicin hydrochloride, cisplatin, paclitaxel)
- description
- Patients receive doxorubicin hydrochloride IV over 30 minutes followed by cisplatin IV over 1 hour on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive doxorubicin hydrochloride IV and cisplatin IV or IP on day 1, and paclitaxel IP on days 1 or 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Cisplatin
- Drug: Doxorubicin Hydrochloride
- Biological: Filgrastim
- Drug: Paclitaxel
- Biological: Pegfilgrastim
Primary outcomes (3)
- measure
- Incidence of observed DLTs, defined as grade 3-4 hematologic or non-hematologic toxicity graded using CTCAE v3.0
- timeFrame
- 18 weeks
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Patients with stage IIIA, or stage IIIC with positive cytologic washings/ascites, adnexal spread, or serosal involvement, or stage IV (by virtue of intraperitoneal disease spread) histologically confirmed endometrial cancer (endometrioid, serous, clear cell, squamous/adenosquamous, undifferentiated, or mixed histologies) * Patients must be optimally cytoreduced with less than or equal to 2 cm residual disease * Absolute neutrophil count (ANC) greater than or equal to 1,500/mm\^3, equivalent to Common Toxicity Criteria (Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0 \[v3.0\]) grade 1 * Platelets greater than or equal to 100,000/mm\^3 (CTCAE v3.0 grade 0-1) * Hemoglobin greater than or equal to 10 g/dl (CTCAE v3.0 grade 1) * Creatinine less than or equal to 2 mg/% or 24 hour creatinine clearance \> 50 ml/min * Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (CTCAE v3.0 grade 1) * Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1) * Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1 * Patients must have normal ejection fraction * Patients must be enrolled within 8 weeks of surgery * Patients who have met the pre-entry requirements * Patients must have signed an approved informed consent and authorization permitting release of personal health information * Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 Exclusion Criteria: * Metastatic disease involving lung or liver parenchyma, bone or inguinal or scalene lymph nodes * Patients with GOG performance grade of 3 or 4 * Patients with concomitant medical illness such as serious uncontrolled infection, uncontrolled angina, or serious peripheral neuropathy, which in the opinion of the treating physician, makes the protocol prescribed treatments hazardous to the patient * Patients with 3rd degree or complete heart block are not eligible unless a pacemaker is in place; patients who are on medications which alter cardiac conduction (digitalis, beta blockers, calcium channel blockers) or who have other cardiac conduction abnormalities may be placed on study at the discretion of the investigator * Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy * Patients who have received prior radiation or chemotherapy for the cancer being treated in this study
References
Publications (0)
Data not yet available
No reference posted for this study.