Erlotinib Plus Carboplatin and Paclitaxel in Ovarian Carcinoma
Condition: Brenner Tumor; Fallopian Tube Cancer; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mucinous Cystadenocarcinoma; Ovarian Serous Cystadenocarcinoma; Ovarian Undifferentiated Adenocarcinoma; Stage III Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer
MeSH terms: Adenocarcinoma; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Carcinoma, Endometrioid; Cystadenocarcinoma; Cystadenocarcinoma, Serous; Cystadenocarcinoma, Mucinous; Brenner Tumor
Intervention: paclitaxel; carboplatin; erlotinib
Intervention description: Given IV; Given IV; Given PO
Intervention MeSH terms: Paclitaxel; Carboplatin; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying the side effects of giving erlotinib together with
      carboplatin and paclitaxel and to see how well it works in treating patients with stage III
      or stage IV ovarian, fallopian tube, or primary peritoneal cancer. Biological therapies such
      as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor.
      Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop
      tumor cells from dividing so they stop growing or die.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a histologic diagnosis of primary peritoneal carcinoma, fallopian tube
             epithelial ovarian carcinoma, Stage III with either greater than 1 cm (suboptimal)
             residual disease following initial surgery, or Stage IV; all patients must either have
             had appropriate surgery for ovarian, fallopian tube or peritoneal carcinoma with
             appropriate tissue available for histologic evaluation to confirm diagnosis and stage
             or must be unresectable at time of diagnosis (to be determined by gynecological
             oncologist); cytology alone is not adequate

          -  Patients with the following histologic epithelial cell types are eligible: Serous
             adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated
             carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell
             carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (NOS)

          -  Patients must begin chemotherapy on this study no more than twelve weeks
             postoperatively

          -  Patients must not have received chemotherapy within five years prior to enrollment

          -  ECOG performance status =< 2 (Karnofsky >= 60%)

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  Total bilirubin =< 1.5 x institutional upper limit of normal

          -  AST(SGOT)/ALT(SGPT) =< 2.5 x institutional upper limit of normal

          -  Creatinine =< 1.5 x institutional upper limit of normal OR creatinine clearance >= 60
             mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

          -  Neuropathy (sensory and motor) =< CTC grade 1

          -  No medical contraindications to planned regimen

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients who have had courses of chemotherapy within the five years prior to entering
             the study

          -  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 OSI-774 or other agents used in the study

          -  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 because OSI-774 has the potential for
             teratogenic or abortifacient effects; because there is an unknown but potential risk
             for adverse events in nursing infants secondary to treatment of the mother with
             OSI-774, breastfeeding should be discontinued if the mother is treated with OSI-774;
             these potential risks may also apply to other agents used in this study

          -  Because patients with immune deficiency are at increased risk of lethal infections
             when treated with marrow-suppressive therapy, HIV-positive patients receiving
             combination anti-retroviral therapy are excluded from the study because of possible
             pharmacokinetic interactions with OSI-774 or other agents administered during the
             study; appropriate studies will be undertaken in patients receiving combination
             anti-retroviral therapy when indicated