Completed

A Dose-Escalating Phase I Study With an Expanded Cohort to Assess the Feasibility of Intraperitoneal Carboplatin (NSC #214240) and Intravenous Paclitaxel (NSC # 673089) and Intravenous Paclitaxel, Intraperitoneal Carboplatin and NCI Supplied Intravenous Bevacizumab (NSC #704865) in Patients With Previously Untreated Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma

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What is being tested

adjuvant therapy

+ paclitaxel

+ carboplatin

ProcedureDrugBiological
Who is being recruted

Carcinoma, Ovarian Epithelial+31

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: June 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2004

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of intraperitoneal carboplatin when administered with paclitaxel during course 1, in patients with stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer who had initial debulking surgery. II. Determine the feasibility of this regimen in these patients. III. Determine the feasibility of adding IV bevacizumab to this regimen in courses 2-6. SECONDARY OBJECTIVES: I. Determine the toxicity profile of this regimen in these patients. II. Determine the toxicity profile of paclitaxel and bevacizumab IV in combination with intraperitoneal carboplatin in these patients. III. Determine the response rate (in patients with measurable disease who are in the expanded cohort) and progression-free survival of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of intraperitoneal carboplatin. Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1 in course 1. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated dose (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. Once the MTD is determined, an additional 20-40 patients are treated at that dose level. Patients are followed every 3 months for 1 year.

Official TitleA Dose-Escalating Phase I Study With an Expanded Cohort to Assess the Feasibility of Intraperitoneal Carboplatin (NSC #214240) and Intravenous Paclitaxel (NSC # 673089) and Intravenous Paclitaxel, Intraperitoneal Carboplatin and NCI Supplied Intravenous Bevacizumab (NSC #704865) in Patients With Previously Untreated Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma 
NCT00079430
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

113 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Carcinoma, Ovarian EpithelialUrogenital DiseasesGenital DiseasesAdenocarcinomaAdnexal DiseasesBrenner TumorCarcinomaCystadenocarcinomaEndocrine System DiseasesEndocrine Gland NeoplasmsFallopian Tube DiseasesFallopian Tube NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Connective TissueNeoplasms, Glandular and EpithelialOvarian DiseasesOvarian NeoplasmsUrogenital NeoplasmsUterine NeoplasmsEndometrial NeoplasmsNeoplasms, Connective and Soft TissueNeoplasms, Fibrous TissueNeoplasms, FibroepithelialCarcinoma, EndometrioidCystadenocarcinoma, MucinousCystadenocarcinoma, SerousNeoplasms, Cystic, Mucinous, and SerousFemale Urogenital Diseases

Criteria

Inclusion Criteria: * Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer * Stage II-IV disease * 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's tumor * Optimal (≤ 1 cm residual disease) OR suboptimal residual disease after initial debulking surgery (performed within the past 12 weeks) * Synchronous primary endometrial cancer OR prior history of endometrial cancer allowed provided all of the following are true: * Stage IB disease or less * Less than 3 mm invasion without vascular or lymphatic invasion * No poorly differentiated subtypes, including the following: * Papillary serous * Clear cell * Other FIGO grade 3 lesions * No epithelial tumors of low malignant potential (borderline tumors) * No CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, or brain metastases by history or evidence upon physical examination within the past 6 months * Performance status - GOG 0-2 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * INR ≤ 1.5 * PTT \< 1.2 times upper limit of normal (ULN) * No active bleeding or pathologic conditions carrying high risk of bleeding (e.g., known bleeding disorder, coagulopathy, or tumor involving major vessels) * AST ≤ 3 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 3 times ULN * Bilirubin ≤ 1.5 times ULN * No acute hepatitis * Creatinine ≤ 2.0 mg/dL * Urine protein-creatinine ratio \< 1.0 OR protein 1.0 g by 24 hour urine collection * Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided the patient's cardiac status has been stable for ≥ 6 months before study entry * No clinically significant cardiovascular disease, including any of the following: * Uncontrolled hypertension, defined as systolic BP \> 150 mm Hg or diastolic BP \> 90 mm Hg * Myocardial infarction or unstable angina within the past 6 months * New York Heart Association class II-IV congestive heart failure * Serious cardiac arrhythmia requiring medication * Peripheral vascular disease ≥ CTCAE grade 2 (at least brief (\< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit) * No history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within the past 6 months * Not pregnant or nursing * Fertile patients must use effective contraception during and for ≥ 6 months after completion of bevacizumab therapy * No neuropathy (sensory and motor) \> grade 1 * No active infection requiring antibiotics * No circumstances that would preclude study participation * No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies * No history of allergic reaction to polysorbate 80 (e.g., etoposide, vitamin E) * No other invasive malignancies within the past 5 years except non-melanoma skin cancer or localized breast cancer * No serious, non-healing wound, ulcer, or bone fracture * No significant traumatic injury within 28 days prior to bevacizumab therapy * No prior history of abdominal fistula or gastrointestinal perforation within the past 3-6 months * Granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection allowed but require weekly wound examinations * No clinical symptoms or signs of gastrointestinal obstruction requiring parenteral hydration and/or nutrition * At least 28 days since intra-abdominal abscess and recovered * At least 3 years since prior adjuvant chemotherapy for localized breast cancer * Patients must remain free of recurrent or metastatic disease * At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin * Patient must remain free of recurrent or metastatic disease * No prior radiotherapy to any portion of the abdominal cavity or pelvis * No concurrent amifostine or other protective agents * No concurrent major surgical procedure or open biopsy or within 28 days prior to bevacizumab therapy * No core biopsy within 7 days prior to bevacizumab therapy * No prior therapy for this malignancy * No prior cancer treatment that contraindicates study therapy * No prior anti-VEGF drug, including bevacizumab

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1 in course 1. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 19 locations

Suspended

University of California Medical Center At Irvine-Orange Campus

Orange, United StatesSee the location
Suspended

University of Chicago

Chicago, United States
Suspended

University of Iowa Hospitals and Clinics

Iowa City, United States
Suspended

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, United States
Completed19 Study Centers