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Phase I Dose-Escalation Parallel Studies of Intraperitoneal Oxaliplatin With Intravenous Docetaxel and Intravenous Oxaliplatin With Intraperitoneal Docetaxel in Platinum-Sensitive or Platinum-Resistant Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

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Trial Information

Phase I Dose-Escalation Parallel Studies of Intraperitoneal Oxaliplatin With Intravenous Docetaxel and Intravenous Oxaliplatin With Intraperitoneal Docetaxel in Platinum-Sensitive or Platinum-Resistant Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancer


This is a non-randomized, open-label Phase I trial in patients with previously treated,
recurrent ovarian, primary peritoneal, or fallopian tube cancer. Patients may have either
platinum -sensitive (relapse > 12 months from primary therapy) or platinum-resistant
(relapse ≤ 12 months from primary therapy) disease.

Up to 20 patients will be enrolled into each of the following arms:

- Arm 1 patients will receive intravenous docetaxel at standard dosing of 75 mg/m2 over 1
hour on day #1 followed by intraperitoneal oxaliplatin on day #2 until maximum
tolerated dose is achieved.

- Arm 2 patients will receive intravenous oxaliplatin at standard dosing of 75 mg/m2 over
1 hour on day #1 followed by intraperitoneal docetaxel on day #2 until maximum
tolerated dose is achieved.

Treatment will be repeated every 3 weeks until disease progression, intolerable toxicity.


Inclusion Criteria:



- Recurrent histologically confirmed platinum-sensitive or platinum-resistant ovarian,
primary peritoneal, or fallopian tube cancer

- Subjects may not have had > 3 prior regimens and must not have had a platinum or
taxane agent within the past 6 months. Last chemotherapy must have been > 4 weeks
prior to enrollment. Subjects may not have had prior whole abdomen or pelvic
radiation. Patients may not have had > 6 cycles of an alkylating agent or > 450 mg/m2
of doxorubicin.

- ECOG Performance Score of ≤2 (Appendix A)

- Adequate bone marrow as evidenced by:

- Absolute neutrophil count > or equal to 1,500/uL

- Hemoglobin > or equal to 8 g/dl

- Platelet count > or equal to 100,000/uL

- Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL

- Adequate hepatic function as evidenced by:

- Serum total bilirubin < 1.5 mg/dL

- Alk Phos, AST/ALT must be < 3x ULN or <5x ULN if hepatic mets.

- AST/ALT < 3X the ULN for the reference lab

- Patients must be recovered from both the acute and late effects of any prior surgery,
radiotherapy or other antineoplastic therapy

- Patients or their legal representatives must be able to read, understand and provide
informed consent to participate in the trial.

- Patients of childbearing potential and their partners must agree to use an effective
form of contraception during the study and for 90 days following the last dose of
study medication (an effective form of contraception is an oral contraceptive or a
double barrier method)

Exclusion Criteria:

- Patients with an active infection or with a fever > 101.30 F within 3 days of the
first scheduled day of protocol treatment

- Patients with active extra-abdominal metastases

- Patients with active CNS metastases. Patients with stable CNS disease, who have
undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment
and who have been on a stable dose of corticosteroids for 3 weeks are eligible for
the trial

- History of prior malignancy within the past 5 years except for curatively treated
basal cell carcinoma of the skin or cervical intra-epithelial neoplasia

- Patients with known hypersensitivity to any of the components of docetaxel or
oxaliplatin

- Patients who received pelvic or abdominal radiotherapy

- Patients who are receiving concurrent investigational therapy or who have received
investigational therapy within 30 days of the first scheduled day of protocol
treatment (investigational therapy is defined as treatment for which there is
currently no regulatory authority approved indication)

- Peripheral neuropathy ≤ Grade 2

- Patients who are pregnant or lactating

- Any other medical condition, including mental illness or substance abuse, deemed by
the Investigator to be likely to interfere with a patient's ability to sign informed
consent, cooperate and participate in the study, or interfere with the interpretation
of the results.

- History of allogeneic transplant

- Known HIV or Hepatitis B or C (active, previously treated or both)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safest and maximum tolerated dose regimen for IV oxaliplatin with intraperitoneal docetaxel and IV oxaliplatin with intraperitoneal docetaxel in patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer.

Outcome Time Frame:

18 months

Safety Issue:

Yes

Principal Investigator

Robert P Edwards, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Institutional Review Board

Study ID:

OX-06-009

NCT ID:

NCT00692900

Start Date:

December 2008

Completion Date:

June 2013

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Magee-Womens Hospital of UPMCPittsburgh, Pennsylvania  15213