Clinical trial · Interventional
Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
A Dose-Escalating Phase I Study With an Expanded Cohort to Assess the Feasibility of CT-2103 and Carboplatin (NSC #214240) in Patients With Previously Untreated Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma
NCT00060359CI-TRIAL-00017849completedPhase 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 is studying the side effects and best dose of polyglutamate paclitaxel when given together with carboplatin in treating patients with ovarian epithelial, peritoneal, or fallopian tube cancer. Drugs used in chemotherapy such as polyglutamate paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Polyglutamate paclitaxel may be able to deliver the drug directly to tumor cells while leaving normal cells undamaged. Combining polyglutamate paclitaxel with carboplatin 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 |
|---|---|---|---|
| Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Ovarian Mixed Epithelial Tumor | — | UNRESOLVED | — |
| Ovarian Brenner Tumor | Ovarian Brenner Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Clear Cell Cystadenocarcinoma | Ovarian Clear Cell Cystadenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Endometrioid Adenocarcinoma | Ovarian Endometrioid Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Mucinous Cystadenocarcinoma | Ovarian Mucinous Cystadenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Serous Cystadenocarcinoma | Ovarian Serous Cystadenocarcinoma |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel Poliglumex | Drug | — | UNRESOLVED |
| Pharmacological Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (paclitaxel poliglumex, carboplatin)
- description
- DOSE-ESCALATION PHASE: Patients receive CT-2103 IV over 10 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CT-2103 until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first course of treatment. FEASIBILITY PHASE: Once the MTD of CT-2103 is determined, an additional 20-40 patients receive treatment at that dose level combined with carboplatin as above.
- interventionNames
- Drug: Carboplatin
- Drug: Paclitaxel Poliglumex
- Other: Pharmacological Study
Primary outcomes (2)
- measure
- Feasibility, in terms of incidence of DLT, as assessed by CTC version 2.0
- timeFrame
- 84 days (first 4 courses)
- measure
- Maximum tolerated dose (MTD) as assessed by CTC version 2.0
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube carcinoma * Stage III or IV * Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery * The following histologic epithelial cell types are eligible: * Serous adenocarcinoma * Mucinous adenocarcinoma * Clear cell adenocarcinoma * Transitional cell carcinoma * Adenocarcinoma not otherwise specified * Endometrioid adenocarcinoma * Undifferentiated carcinoma * Mixed epithelial carcinoma * Malignant Brenner tumor * No epithelial tumors of low malignant potential (borderline tumors) * Surgery performed within the past 12 weeks * Performance status - GOG 0-2 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No active bleeding * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastasis) * Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastasis) * No acute hepatitis * PT and PTT normal * Creatinine no greater than 1.5 times ULN * Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided cardiac status has been stable for the past 6 months * No myocardial infarction within the past 6 months * No unstable angina * Not pregnant or nursing * Fertile patients must use effective contraception * No neuropathy (sensory or motor) grade 2 or worse * No other invasive malignancies within the past 5 years except nonmelanoma skin cancer or localized breast cancer * No active infection requiring antibiotics * No circumstances that would preclude study completion or follow-up * More than 3 years since prior adjuvant chemotherapy for localized breast cancer (must be free of recurrent or metastatic disease) * More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin (must be free of recurrent or metastatic disease) * No prior radiotherapy to any portion of the abdominal cavity or pelvis * No prior treatment, other than debulking surgery, for this cancer * No prior treatment for another cancer that would contraindicate this protocol therapy * No concurrent amifostine or other protective reagents
References
Publications (0)
Data not yet available
No reference posted for this study.