Clinical trial · Interventional
Erlotinib, Docetaxel, and Carboplatin in Treating Patients With Newly Diagnosed Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
A Phase I-II Study of OSI-774 (Tarceva, Erlotinib) With Docetaxel/Carboplatin Followed by Maintenance Therapy With Tarceva as Treatment for Newly Diagnosed Stage III/IV Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer
- 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: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib together with docetaxel and carboplatin may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with docetaxel and carboplatin and to see how well they work in treating patients with newly diagnosed stage III or stage IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer.
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 |
| Peritoneal Cavity Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum tolerated dose of erlotinib
Secondary outcomes (5)
- measure
- Toxicity of maintenance therapy
- measure
- Proportion of patients who receive the full schedule of treatment courses
- measure
- Response rate
- measure
- Progression-free survival
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer * Stage III or IV disease * The following histologic epithelial cell types are allowed: * Serous adenocarcinoma * Mucinous adenocarcinoma * Clear cell adenocarcinoma * Endometrioid adenocarcinoma * Mixed epithelial carcinoma * Undifferentiated carcinoma * Transitional cell carcinoma * Malignant Brenner tumor * Adenocarcinoma not otherwise specified * Must have undergone appropriate surgery for ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer within the past 6 weeks * No borderline ovarian tumor of low malignant potential PATIENT CHARACTERISTICS: Age * 18 and over Performance status * GOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 8.0 g/dL * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin normal * Meets 1 of the following criteria: * Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN) * AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN * AP ≤ 5 times ULN AND AST or ALT normal * No hepatic disease that would preclude study participation Renal * Creatinine ≤ 2.0 mg/dL * Creatinine clearance \> 50 mL/min * No renal disease that would preclude study participation Cardiovascular * LVEF ≥ lower limit of normal\* * No poorly controlled arrhythmia * No unstable coronary artery disease * No myocardial infarction within the past year NOTE: \*LVEF evaluation performed only on patients requiring it Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment * No peripheral neuropathy ≥ grade 2 * No other nonmalignant systemic disease that would preclude study participation * No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No medical, social, or psychosocial factor that would preclude study participation * No psychiatric or addictive disorder that would preclude giving informed consent * No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy for this malignancy Chemotherapy * No prior chemotherapy for this malignancy Endocrine therapy * No prior hormonal therapy for this malignancy Radiotherapy * No prior radiotherapy for this malignancy Surgery * See Disease Characteristics * No planned interval cytoreductive surgery * Second-look surgery allowed Other * More than 1 year since prior experimental or investigational therapy * No concurrent therapeutic anticoagulation with warfarin
References
Publications (0)
Data not yet available