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Phase I Trial of Intraperitoneal Nab-Paclitaxel (Abraxane) in the Treatment of Advanced Malignancies Primarily Confined to the Peritoneal Cavity

Phase 1
18 Years
Open (Enrolling)
Ovarian Cancer, Peritoneal Cavity Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Trial of Intraperitoneal Nab-Paclitaxel (Abraxane) in the Treatment of Advanced Malignancies Primarily Confined to the Peritoneal Cavity

PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of nab-paclitaxel as
a single agent administered intraperitoneally via an intraperitoneal catheter.

SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetics of nab-paclitaxel (Abraxane) in
the plasma and peritoneum when it is administered directly into the peritoneal cavity. II.
To determine the potential pharmacokinetic advantage (favorable ratio of nab-paclitaxel
(Abraxane) concentration in the peritoneal cavity vs. plasma) for nab-paclitaxel
administered intraperitoneally. III. To determine the progression of peripheral neuropathy
in patients treated with intraperitoneal chemotherapy on this study through pre-treatment
and sequential evaluation of the Neuropathic Pain Syndrome Inventory and Serial Nerve
Conduction Studies.

OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation given
intraperitoneally (IP) on days 1, 8, and 15. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Inclusion Criteria:

- Patients must have histological confirmed advanced cancer primarily confined to the
peritoneal cavity which have progressed on previous chemotherapeutic regimens, or for
which no "standard" chemotherapeutic regimens exist

- Prior taxane exposure is allowed; prior IP chemotherapy is allowed, if it was not
complicated by peritoneal adhesions; patients with ovarian cancer having residual
disease at second-look laparotomy or following secondary debulking are also eligible;
patients must be 4-6 weeks after surgery and they must have recovered from the
surgery prior to initiating IP chemotherapy

- Eastern Cooperative Oncology Group (ECOG) less than or equal to 2

- Life expectancy of greater than 3 months

- Absolute neutrophil count > 1,500/mcL

- Platelets > 100,000/mcL

- Total bilirubin within normal institutional limits

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) <
2.5 x institutional upper limit of normal

- Creatinine within normal institutional limits or creatinine clearance > 60
mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

- Documentation of measurable disease (with baseline measurements taken with 4 weeks of
study entry, when present and appropriate); presence of measurable disease is not,
per se, a prerequisite for entry onto this study

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation; should a woman become pregnant or suspect
she is pregnant while participating in this study, she should inform her treating
physician immediately

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administer more than 4 weeks earlier;
there is no limit on the number of prior lines of chemotherapy

- Patients may not be receiving any other investigational agents

- Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse events

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to nab-paclitaxel

- Patients with ongoing abdominal infections or bowel obstruction

- Patients with known peritoneal adhesions that preclude the placement of an
intraperitoneal catheter in the opinion of the surgeon placing the intraperitoneal

- Pre-existing grade >= 2 sensory neuropathy

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with nab-paclitaxel

- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral

- "Massive Ascites" requiring therapeutic paracentesis, will not be cause for
ineligibility, per se, it will be evaluated on an individual basis; investigators who
have any questions regarding assessing ascites are asked to speak with the Principal

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

28 days following the first course of treatment in which 2 or more patients experience a Dose Limiting Toxicity

Safety Issue:


Principal Investigator

Mihaela Cristea, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

December 2008

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • peritoneal carcinomatosis
  • peritoneal cavity cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • unspecified adult solid tumor, protocol specific
  • Ovarian Neoplasms
  • Peritoneal Neoplasms



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